DailyMed - EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

NDC Code(s): 0067-2021-20, 0067-2021-24, 0067-2021-80
Packager: Haleon US Holdings LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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Active ingredients (in each GelTab)
Acetaminophen 250 mg - Aspirin 250 mg (NSAID)* Caffeine 65 mg - *nonsteroidal anti-inflammatory drug

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug
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Purposes
Pain reliever - Pain reliever - Pain reliever aid

Pain reliever

Pain reliever

Pain reliever aid
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Uses
• temporarily relieves minor aches and pains due to: • headache - • a cold - • arthritis - • muscular aches - • toothache - • premenstrual & menstrual cramps

•

temporarily relieves minor aches and pains due to:

•

headache

•

a cold

•

arthritis

•

muscular aches

•

toothache

•

premenstrual & menstrual cramps

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Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea ...

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

•

hives

•

facial swelling

•

asthma (wheezing)

•

shock

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

•

more than 8 geltabs 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

•

are age 60 or older

•

have had stomach ulcers or bleeding problems

•

take a blood thinning (anticoagulant) or steroid drug

•

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

•

have 3 or more alcoholic drinks every day while using this product

•

take more or for a longer time than directed

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 heart beat.

Do not use

•

if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer

•

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

•

stomach bleeding warning applies to you

•

you have a history of stomach problems, such as heartburn

•

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

•

you are taking a diuretic

•

you have asthma

Ask a doctor or pharmacist before use if you are

taking

•

a prescription drug for diabetes, gout, or arthritis

•

any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

•

an allergic reaction occurs. Seek medical help right away.

•

you experience any of the following signs of stomach bleeding:

•

feel faint

•

vomit blood

•

have bloody or black stools

•

have stomach pain that does not get better

•

ringing in the ears or loss of hearing occurs

•

painful area is red or swollen

•

pain gets worse or lasts for more than 10 days

•

fever gets worse or lasts for more than 3 days

•

any new symptoms appear

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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.

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Directions
• do not use more than directed - • drink a full glass of water with each dose - • adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 ...

•

do not use more than directed

•

drink a full glass of water with each dose

•

adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours

•

children under 12 years: ask a doctor

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Other information
• store at 20°-25°C (68°-77°F) • close cap tightly after use - • read all product information before using. Keep this box for important information.

•

store at 20°-25°C (68°-77°F)

•

close cap tightly after use

•

read all product information before using. Keep this box for important information.

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Inactive ingredients
benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl ...

benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol syrup, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide
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Questions?
1-800-452-0051

1-800-452-0051
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Principal Display Panel
NDC 0067-2021-20 - EXCEDRIN - EXTRA STRENGTH - Acetaminophen, Aspirin (NSAID) and Caffeine - Pain Reliever/Pain Reliever Aid - 20 GELTABS - TAMPER-EVIDENT BOTTLE - DO NOT USE IF INNER FOIL SELA ...

NDC 0067-2021-20

EXCEDRIN

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

20 GELTABS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SELA IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

©2015 GSK or its licensor.

Visit us at www.excedrin.com

46172149

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INGREDIENTS AND APPEARANCE

Product Information

EXCEDRIN EXTRA STRENGTH GELTABS acetaminophen, asprin, caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-2021
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MALTITOL (UNII: D65DG142WK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PEPSIN (UNII: GID333S43J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN (dark green) , WHITE	Score	no score
Shape	ROUND	Size	18mm
Flavor		Imprint Code	E
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0067-2021-20	1 in 1 CARTON	09/13/2011
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0067-2021-24	1 in 1 CARTON	09/13/2011
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0067-2021-80	1 in 1 CARTON	09/13/2011
3		80 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	09/13/2011

Labeler - Haleon US Holdings LLC (079944263)

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Published Date (What is this?)	Version	Files
Mar 7, 2024	6 (current)	download
Dec 7, 2020	5	download
Jul 27, 2018	4	download
Apr 4, 2017	3	download
Aug 24, 2015	2	download
Sep 14, 2012	1	download

	RxCUI	RxNorm NAME	RxTTY
1	209468	EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet	PSN
2	209468	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]	SBD
3	209468	APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]	SY
4	209468	Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY
5	209468	Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY
6	209468	Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY
7	308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN
8	308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD
9	308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY

Label: EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	0067-2021-20
2	0067-2021-24
3	0067-2021-80

Label: EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

Number of versions: 6

EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

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EXCEDRIN EXTRA STRENGTH GELTABS- acetaminophen, asprin, caffeine tablet, coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.