Label: ACETAMINOPHEN , ASPIRIN AND CAFFEINE- acetaminophen , aspirin and caffeine capsule

  • NDC Code(s): 35916-0709-1
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2026

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

  • Active ingredients (in each geltab)

    Acetaminophen 250 mg
    Aspirin 250 mg

    Caffeine 65 mg

  • PURPOSE

    Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor aches and pains due to:
    • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps

  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-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 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 as much caffeine as a 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 occasional rapid heartbeat.

  • DO NOT USE

    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 DOCTOR

    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 DOCTOR/PHARMACIST

    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

    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.

  • PREGNANCY OR BREAST FEEDING

    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 complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions
    • do not use more than directed (see overdose warning)
    • 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 SAFETY INFORMATION

    Other information

    • store at room temperature between 20-25°C(68-77°F)
    • avoid excessive heat, cold and humidity

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN , ASPIRIN AND CAFFEINE 
    acetaminophen , aspirin and caffeine capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0709
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colorgreen (Dark green - white) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0709-11500 in 1 BAG; Type 0: Not a Combination Product01/10/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/08/2026
    Labeler - Softgel Healthcare Pvt Ltd (676666501)