Label: ACETAMINOPHEN ES- pharbetol tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-028-30, 67046-028-60, 67046-028-62 - Packager: Contract Pharmacy Services-PA
- This is a repackaged label.
- Source NDC Code(s): 16103-376
- 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 April 22, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this productDo 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 and ask doctor before use if:
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.
Directions
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do not take more than directed (see overdose warning).
- Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
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Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN ES
pharbetol tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-028(NDC:16103-376) 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 POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code PH044 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67046-028-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/10/2006 2 NDC:67046-028-60 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/10/2006 3 NDC:67046-028-62 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/10/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/10/2006 Labeler - Contract Pharmacy Services-PA (945429777) Establishment Name Address ID/FEI Business Operations Coupler Enterprises Inc. 945429777 repack(67046-028)
