Label: ONLY FOR HEADACHE- acetaminophen, aspirin, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 18, 2020

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

  • 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, naproxen 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)

  • SPL UNCLASSIFIED SECTION

    ADULT

    PAIN RELIEVER

    PAIN RELIEVER AID

    TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing

    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

  • INGREDIENTS AND APPEARANCE
    ONLY FOR HEADACHE 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem 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 CARTON11/15/2020
    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
    Labeler - O4 Global Trading Usa, Llc (081226861)