Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, liquid filled
- NDC Code(s): 49738-024-25, 49738-024-26
- Packager: Kmart Corporation
- 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.
Drug Label Information
Updated November 21, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Uses
-
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
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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
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - Bottle Label 40ct
- PRINCIPAL DISPLAY PANEL - Bottle Label 80ct
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49738-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (clear) Score no score Shape capsule (oblong) Size 27mm Flavor Imprint Code PC24 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49738-024-25 40 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2016 2 NDC:49738-024-26 80 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/01/2016 Labeler - Kmart Corporation (008965873) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture(49738-024) , analysis(49738-024)