Label: PHARBETOL- acetaminophen tablet
- NDC Code(s): 16103-376-06, 16103-376-08, 16103-376-11
- Packager: Pharbest Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- 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 4000 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).
adult and children 12 years and over
- take 2 tablets, every 4 to 6 hours while symptoms last
- do not take more than 6 tablets 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?
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PRINCIPAL DISPLAY PANEL
PHARBEST
NDC 16103-376-11
manufactured in the USA
Extra Strength Contains no Aspirin
*Compare to the active ingredient in Extra Strength Tylenol® Caplet
PHARBETOL
Acetaminophen 500mg
Pain Reliever/ Fever Reducer
THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN
1000 TABLETS
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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INGREDIENTS AND APPEARANCE
PHARBETOL
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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, UNSPECIFIED (UNII: FZ989GH94E) 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:16103-376-06 1 in 1 CARTON 01/10/2006 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:16103-376-08 1 in 1 CARTON 01/10/2006 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:16103-376-11 1000 in 1 BOTTLE, PLASTIC; 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 Drug M 01/10/2006 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 analysis(16103-376) , manufacture(16103-376) , pack(16103-376) , label(16103-376)