Label: ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG tablet
- NDC Code(s): 0363-1320-12, 0363-1320-23, 0363-1320-80
- Packager: WALGREENS CO.
- 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.
Updated September 24, 2019
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- ACTIVE INGREDIENT
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, lactose monohydrate, light liquid paraffin, microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac glaze, sorbitol sorbitan, stearic acid, talc, titanium dioxide, triacetin.
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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 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 contains acetaminophen, 3 or more alcoholic drinks every day while using this product.
Stomach bleeding warning: This contains an NSAID, which mat 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 product, take more or for a longer time than direct.
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, occasionally, rapid heartbeat.
Do not use if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/ fever, 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 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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG
acetaminophen 250mg aspirin 250mg caffeine 65mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1320 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SORBITOL SOLUTION (UNII: 8KW3E207O2) TALC (UNII: 7SEV7J4R1U) SHELLAC (UNII: 46N107B71O) TRIACETIN (UNII: XHX3C3X673) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LIGHT MINERAL OIL (UNII: N6K5787QVP) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) GLYCERIN (UNII: PDC6A3C0OX) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color green (Dark Green - White) Score no score Shape ROUND Size 13mm Flavor Imprint Code S77 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1320-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2019 2 NDC:0363-1320-80 80 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2019 3 NDC:0363-1320-23 20 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/24/2019 Labeler - WALGREENS CO. (008965063)