Label: PANADOL EXTRA- acetaminophen and caffeine tablet, film coated
- NDC Code(s): 0135-0620-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- 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.
Updated February 13, 2017
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- Active ingredient (in each caplet)
Acetaminophen 500 mg
Caffeine 65 mgClose
Pain reliever aidClose
temporarily relieves minor aches and pains due to:
- muscular aches
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: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
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, caffeine or any of the other ingredients in this product
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms occur
These could be signs of a serious condition.
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not use more than directed (see overdose warming)
- adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
- do not take more than 8 caplets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- store at 20°-25°C (68°-77°F)
- close cap tightly after use
- Inactive ingredients
benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Pain Reliever Aid
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
©2016 GSK group of companies or its licensor. All rights reserved.
Trademarks are owned by or licensed to the GSK group of companies.
- INGREDIENTS AND APPEARANCE
acetaminophen and caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0620 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED Score no score Shape OVAL (Caplet) Size 17mm Flavor Imprint Code ETH Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0620-01 1 in 1 CARTON 03/01/2017 1 24 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 03/01/2017 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)