Label: PHARBETOL REGULAR STRENGTH- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-023-30, 67046-023-60, 67046-023-62 - Packager: Coupler Enterprises
- This is a repackaged label.
- Source NDC Code(s): 16103-353
- 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 February 24, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (per tablet)
- Purpose
- Uses
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Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if
- Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing acetaminophen
- Adult has 3 or more alcoholic drinks every day while using this product
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
Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
These could be sign of a serious condition.
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Directions
- do not take more than directed (see overdose warning).
Adults and children 12 years and over
Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours.
Children 6 to under 12 years
Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours.
Children under 6 years
Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- Other information
- Inactive ingredients:
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHARBETOL REGULAR STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-023(NDC:16103-353) 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 POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code PH020 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67046-023-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/09/2007 2 NDC:67046-023-60 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/09/2007 3 NDC:67046-023-62 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/09/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/09/2007 Labeler - Coupler Enterprises (945429777) Establishment Name Address ID/FEI Business Operations Coupler Enterprises 945429777 repack(67046-023)