OTC Medication Information: Acetaminophen 250mg Aspirin 250mg Caffeine 65mg

ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG- acetaminophen, aspirin and caffeine tablet
CVS Pharmacy

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.

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

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.

  • 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

Temporarily relieves minor aches and pains due to:

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

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.

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.

Pain reliever

Pain reliever

Pain reliever aid

  • 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.

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ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG
acetaminophen 250mg aspirin 250mg caffeine 65mg tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-591
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
GELATIN
D&C YELLOW NO. 10
PROPYLENE GLYCOL
STEARIC ACID
TITANIUM DIOXIDE
LIGHT MINERAL OIL
ETHYLCELLULOSE, UNSPECIFIED
GLYCERIN
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)
POVIDONE, UNSPECIFIED
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
STARCH, CORN
AMMONIA
MICROCRYSTALLINE CELLULOSE
SORBITOL SOLUTION
TALC
SHELLAC
TRIACETIN
HYPROMELLOSES
Product Characteristics
Color green (Dark Green — White) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code S77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-591-20 200 TABLET in 1 BOTTLE None
2 NDC:69842-591-80 80 TABLET in 1 BOTTLE None
3 NDC:69842-591-23 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/01/2021
Labeler — CVS Pharmacy (062312574)

Revised: 01/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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