PANADOL EXTRA- acetaminophen and caffeine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 500 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Pain reliever aid
Authorization status:
OTC monograph not final
Authorization number:
0135-0620-01

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.

----------

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

temporarily relieves minor aches and pains due to:

headache

muscular aches

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

skin reddening

blisters

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

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

Other information

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

if you are allergic to acetaminophen, caffeine or any of the other ingredients in this product

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

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

store at 20°-25°C (68°-77°F)

close cap tightly after use

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

PANADOL EXTRA

acetaminophen and caffeine tablet, film coated

®

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 135-0 6 20

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

S core

no sco re

S hap e

OVAL (Caplet)

S iz e

17mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 135-0 6 20 -0 1

1 in 1 CARTON

0 3/0 1/20 17

1

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 3/0 1/20 17

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Labeler -

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 10/2019

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