PANADOL EXTRA- acetaminophen and caffeine tablet, film coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches

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: 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.

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

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

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.

Directions

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 dioxide

Questions or comments?

1-800-455-7139

Principal Display Panel

NDC 0135-0620-01

Panadol®

EXTRA

ACETAMINOPHEN

Pain Reliever

CAFFEINE

Pain Reliever Aid

NEW

24 CAPLETS

TAMPER-EVIDENT BOTTLE

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.

62000000011138

C:\Users\sh821028\Panadol_Caplets_24 count_carton.jpg
PANADOL  EXTRA
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)

Revised: 2/2017
Document Id: e5c2d88a-d903-4ca0-b895-f27e791dfc4e
Set id: e5c2d88a-d903-4ca0-b895-f27e791dfc4e
Version: 1
Effective Time: 20170213
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC