1. Home
  2. Labeler Index
  3. Cvs Pharrmacy
  4. 69842-636
  5. Label Information: Cvs Health Extra Strength Acetaminophen Softgels

FDA Label for Cvs Health Extra Strength Acetaminophen Softgels

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. OTC - QUESTIONS
    17. PRINCIPAL DISPLAY PANEL

Cvs Health Extra Strength Acetaminophen Softgels Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharrmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


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.