Label: ONLY FOR FIRST AID MEDICINE- diphenhydramine hcl, acetaminophen, aspirin, caffeine kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2020

If you are a consumer or patient please visit this version.

  • ONLY FOR HEADACHE- acetaminophen, aspirin, caffeine tablet

    Drug Facts

  • Active ingredient (in each geltab)

    Acetaminophen 250mg

    Aspirin 250mg (NSAID*)

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses:

    Temporarily relieves minor aches and pains due to:

    • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

  • Warnings:

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flue-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 geltabs in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

    Caffeine warning: The recommended dose of this product contains about a much caffeine as cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heart beat.

    Do not use • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma

    Ask a doctor or pharmacist before use if you are taking

    • a prescription drug for diabetes, gout, or arthritis

    • any other drug, or are under a doctor's care for any serious condition

    Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • ringing in the ears or loss of hearing occurs • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • any new symptoms occur

    These could be signs of a serious condition

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or compliments during delivery.

    Keep out of reach of children.

    OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case overdose. get medical help or contact a Poison Control Center right away.

  • Directions:

    • do not use more than directed

    • drink a full glass of water with each dose

    • adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours

    • children under 12 years: ask a doctor

  • Other Information:

    • store at room temperature between 20-25°C (68 to 77°F) • avoid excessive heat, cold and humidity • close cap tightly after use • read all product information before using.           

  • Inactive Ingredients:

    ammonium hydroxide, black iron oxide, brilliant blue FCF, corn starch, D&C yellow No.10 lake, ethyl cellulose, FD&C blue No.1 lake, FD&C red No.40 lake, gelatin, glycerin, hydroxypropyl methyl cellulose, isopropyl alcohol, isopropyl alcohol - butyl alcohol, lactose monohydrate, light liquid paraffin, microcrystalline cellulose, polysorb 85/70/00, povidone K30, pregelatinised starch, propylene glycol, purified water, shellac glaze, stearic acid, talc, titanium dioxide, triacetin

  • Questions or comments?

    1-833-665-9444. (Mon-Fri 9am-5pm)             

  • ONLY FOR ALLERGY- diphenhydramine hcl tablet

    Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25mg

  • Purpose

    Antihistamine

  • Uses:

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
       • runny nose
       • sneezing
       • itchy, watery eyes
       • itching of the nose or throat

    • temporarily relieves these symptoms due to the common cold:
       • runny nose
       • sneezing

  • Warnings:

    Do not use
    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin.

    Ask a doctor before use if you have
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are 

    taking sedatives or tranquilizers

    When using this product
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children.

    If pregnant or breast-feeding,
    ask a health professional before use.

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away.             

  • Directions:

    • take every 4 to 6 hours, or as directed by doctor

    • do not take more than 6 doses in 24 hours

     adults and children 12 years and over• take 1 to 2 caplets
     children 6 to under 12 years • take 1 caplet


  • Other Information:

    • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
    • avoid excessive heat and light.
    • store in dry place.           

  • Inactive Ingredients:

    croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    1-833-665-9444.
    (Mon-Fri 9am - 5pm)           

  • ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500mg

    Diphenhydramine HCl 25mg

  • Purpose

    Pain reliever

    Nighttime sleep aid

  • Uses:

    • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • Warnings:

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours

    • with other drugs containing acetaminophen

    • 3 or more alcoholic drinks every day while using this product

    Allergy Alert:

    Acetaminophen may cause severe skin reactions.

    Symptoms may include:

    • skin reddening

    • blisters

    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    • with any other product containing diphenhydramine, even one used on skin

    • in children under 12 years of age

    • if you have ever had any allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have

    • liver disease

    • a breathing problem such as emphysema or chronic bronchitis

    • trouble urinating due to an enlarged prostate gland

    • glaucoma.

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin

    • taking sedatives or tranquilizers.

    When using this product

    • drowsiness will occur

    • avoid alcoholic drinks

    • do not drive a motor vehicle or operate machinery.

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    • pain gets worse or lasts more than 10 days

    • fever gets worse or last more than 3 days

    If pregnant or breast-feeding, ask a health professional before use.             

    Keep out of reach of children.

    OVERDOSE WARNINGS: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    • take with a full glass of water

    • Do not take more than directed. SEE OVERDOSE WARNING.

    • do not take more than 2 caplets in 24 hours

    adults and children 12 years of age and over• take 2 caplets at bedtime

    • do not take more than 2 caplets of this product in 24 hours

    children under 12 years of age• do not use

  • Other Information:

    • Store at room temperature between 20-25°C (68-77°F).

    • avoid excessive heat, cold and humidity.

    • close cap tightly after use.

  • Inactive Ingredients:

    colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

  • Questions or comments?

    1-833-665-9444. (Mon-Fri 9am-5pm)

  • ONLY FOR FEVER- acetaminophen tablet

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500mg

  • Purpose

    Pain reliever / Fever reducer

  • Uses:

    • temporary relief minor aches and pains due to:

       • the common cold

       • backache

       • toothache

       • premenstrual and menstrual cramps

       • temporarily reduces fever.

       • headache

       • minor pain of arthritis

       • muscular aches

       • premenstrual and menstrual cramps

    • temporarily reduces fever.

  • Warnings:

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours

    • with other drugs containing acetaminophen

    • 3 or more alcoholic drinks every day while using this product

    Allergy Alert:

    Acetaminophen may cause severe skin reactions.

    Symptoms may include:

    • skin reddening

    • blisters

    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    • if you have ever had any allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have liver disease

    Ask a doctor or pharmacist before use if are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days

    • fever gets worse or last more than 3 days

    • new symptoms occur.

    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. OVERDOSE WARNINGS: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    Do not take more than directed. SEE OVERDOSE WARNING.

     adults and children 12 years of age and over• take 2 caplets every 6 hours while symptoms last

    • do not take more than 6 caplets in 24 hours, unless directed by doctor

    • do not take more than 10 days, unless directed by a doctor

     children under 12 years of age• ask a doctor

  • Other Information:

    • Store at room temperature between 20-25°C (68-77°F).

    • avoid excessive heat, cold and humidity.

    • close cap tightly after use.

  • Inactive Ingredients:

    hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-833-665-9444. (Mon-Fri 9am-5pm)

  • SPL UNCLASSIFIED SECTION

    Only For FIRST AID + MEDICINE KIT

    4 SOLUTIONS

    HEADACHE 25 Geltabs

    ACETAMINOPHEN 250mg / Aspirin (NSAID) 250mg / Caffeine 65mg

    ALLERGY 25 Caplets

    Diphenhydramine HCl 25mg

    BODY PAIN 25 Caplets

    ACETAMINOPHEN 500mg / Diphenhydramine HCl 25mg

    FEVER 25 Caplets

    ACETAMINOPHEN 500mg

    FOR DRUG INFORMATION REVIEW, CHECK BOTTLES THAT COME INSIDE THE BOX


    Distributed By: O4 GLOBAL TRADING USA, LLC.

    12222 Merit Drive, Suite 1900

    Dallas, TX 75251-3209

    www.onlyfor.com

    Packaged By: Strive Pharmaceuticals Inc.

    East Brunswick, NJ 08816.

  • Packaging

    IMAGE

  • PRINCIPAL DISPLAY PANEL

    IMAGE

  • PRINCIPAL DISPLAY PANEL

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ONLY FOR FIRST AID MEDICINE 
    diphenhydramine hcl, acetaminophen, aspirin, caffeine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-350
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-350-981 in 1 BOX; Type 0: Not a Combination Product11/15/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 25 
    Part 21 BOTTLE, PLASTIC 25 
    Part 31 BOTTLE, PLASTIC 25 
    Part 41 BOTTLE, PLASTIC 25 
    Part 1 of 4
    ONLY FOR HEADACHE 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Item Code (Source)NDC:73006-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorgreen (Dark Green - White) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code S77
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-132-951 in 1 CARTON
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/15/2020
    Part 2 of 4
    ONLY FOR ALLERGY 
    diphenhydramine hcl tablet
    Product Information
    Item Code (Source)NDC:73006-148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Caplet) Size11mm
    FlavorImprint Code DP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-148-951 in 1 CARTON
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33811/15/2020
    Part 3 of 4
    ONLY FOR BODY PAIN 
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Item Code (Source)NDC:73006-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (LIGHT BLUE) Scoreno score
    ShapecapsuleSize18mm
    FlavorImprint Code AD01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-120-951 in 1 CARTON
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/15/2020
    Part 4 of 4
    ONLY FOR FEVER 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:73006-143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize17mm
    FlavorImprint Code S500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-143-951 in 1 CARTON
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33811/15/2020
    Labeler - O4 Global Trading Usa, Llc (081226861)