Label: REGULAR STRENGTH PAIN RELIEF- acetaminophen capsule, liquid filled
- NDC Code(s): 27854-388-01
- Packager: Belmora LLC
- Category: HUMAN OTC DRUG LABEL
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 January 5, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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 4 to 6 hours while symptoms last
- do not take more than 10 softgels in 24 hours
- do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
- take 1 softgel every 4 to 6 hours while symptoms last
- do not take more than 5 softgels in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - Carton Label
- PRINCIPAL DISPLAY PANEL - Bottle Label
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INGREDIENTS AND APPEARANCE
REGULAR STRENGTH PAIN RELIEF
acetaminophen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27854-388 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 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 20mm Flavor Imprint Code PC17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27854-388-01 1 in 1 CARTON 01/05/2022 1 20 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/05/2022 Labeler - Belmora LLC (112753244)