Label: PANADOL EXTRA STRENGTH- acetaminophen tablet, film coated
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NDC Code(s):
0135-0609-01,
0135-0609-02,
0135-0609-03,
0135-0609-04, view more0135-0609-05
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 6, 2024
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 caplet)
- Purposes
- Uses
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Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:A‑cetaminophen 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 a acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 0135-0609-01
PANADOL
EXTRA STRENGTH
500
ACETAMINOPHEN
Pain Reliever
Fever Reducer
24 CAPLETS
Trademarks are owned by or licensed to the GSK group of companies.
Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Distributed by:
GSKConsumer Healthcare, Warren, NJ 07059
©2016 GSK group of companies or its licensor.
101596D
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INGREDIENTS AND APPEARANCE
PANADOL EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0609 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 CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL (Caplet) Size 17mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0609-01 1 in 1 CARTON 03/15/2017 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0135-0609-02 1 in 1 CARTON 03/15/2017 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0135-0609-03 1 in 1 CARTON 03/15/2017 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0135-0609-04 50 in 1 CARTON 03/15/2017 4 NDC:0135-0609-05 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/15/2017 Labeler - Haleon US Holdings LLC (079944263)