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Drug Facts
Cvs Health Extra Strength Acetaminophen Softgels
FDA Label NDC 69842-636
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharrmacy for the product Cvs Health Extra Strength Acetaminophen Softgels (NDC 69842-636). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Acetaminophen 500 mg
Purpose
Pain reliever/ fever reducer
Uses
■ temporarily relieves minor aches and pains due to:
■ the common cold ■ headache ■ backache
■ minor pain of arthritis ■ toothache ■ muscular aches
■ premenstrual and menstrual cramps
■ temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
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.
Do Not Use
■ with any other drug containing acetaminophen (prescription
or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.
■ if you are allergic to acetaminophen or any of the inactive
ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - Stop Use
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
do not take more than directed (see Overdose warning)
| Adults and children 12 years and over | ■ take 2 softgels every 6 hours while
symptoms last ■ do not take more than 6 softgels in 24 hours unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor |
| children under
12 years | ask a doctor |
Other Information
■
each softgel contains: sodium 7 mg
■ store between 15°-30°C (59°-86°F)
Inactive Ingredients
FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,
potassium hydroxide, povidone, propylene glycol, purified
water, sodium hydroxide, sorbitol, sorbitol sorbitan solution
titanium dioxide
Otc - Questions
Questions or Comments? 1-888-333-9792
Principal Display Panel
CVS Health
Compare to the active ingredient
in Tylenol® Extra Strength*
Liquid Gels**
EXTRA STRENGTH
Acetaminophen USP 500mg
Pain Reliever; Fever reducer
Aspirin free
40 SOFTGELS**
**Liquid filled capsules
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
This product is not manufactured
or distributed by McNeil Consumer
Healthcare, owner of the
registered trademark Tylenol®
Extra Strength.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
V-35257
#960109
* Please review the disclaimer below.
