ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG tablet

Acetaminophen 250mg Aspirin 250mg Caffeine 65mg by

Drug Labeling and Warnings

Acetaminophen 250mg Aspirin 250mg Caffeine 65mg by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

INACTIVE 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

• 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

INDICATIONS & USAGE

Temporarily relieves minor aches and pains due to:

Headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps

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 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

Keep out of reach of children.

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

PURPOSE

Pain reliever

Pain reliever

Pain reliever aid

OTHER SAFETY INFORMATION

• Store at room temperature between 20-25 ºC (68-77 ºF)
• Avoid excessive heat, cold, and humidity
• Close cap tightly after use
• Read all product information before using. Keep box for important 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)