HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet

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

Buy It Now

Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Western Family Foods, Inc.
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 250 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Pain reliever Pain reliever aid - temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps - headache - a cold - arthritis - muscular aches - sinusitis - toothache - premenstrual & menstrual cramps
Authorization status:
OTC monograph not final
Authorization number:
55312-184-10

HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet

Western Family Foods, Inc.

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 ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Us es

temporarily relieves minor aches and pains due to:

headache

a cold

arthritis

muscular aches

sinusitis

toothache

premenstrual & menstrual cramps

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 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:

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 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

Stomach bleeding warning:

This product contains an NSAID, which may cause 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 an NSAID (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 heartbeat.

Do not use

if you have ever had an allergic reaction to 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

any other drug containing an NSAID (prescription or nonprescription)

a blood thinning (anticoagulant) or steroid drug

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 doctor if

an allergic reaction occurs. Seek medical help right away.

you experience any of the following signs os 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

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.

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 caplets every 6 hours; not more than 8 caplets in 24

hours

children under 12 years: ask a doctor

Other information

store at controlled room temperature 20

- 25 C (68

- 77 F)

excursions permitted to 15 C to 30 C (59 -86 F)

do not use if imprinted safety seal under cap is broken or missing

**this product is not manufactured or distributed by Novartis Consumer Health, owner of the

registered trademark Excedrin® Extra Strength

Inactive ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone,

pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, and triglycerides.

Questions or comments?

1-503-639-6300 Monday- Friday 9AM- 5PM PST

Principal Display Panel

Extra streng th headache relief

HEADACHE RELIEF EXTRA STRENGTH

acetaminophen, aspirin and caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55312-18 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Western Family Foods, Inc.

Ingredient Name

Basis of Strength

Stre ng th

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

ACETAMINOPHEN

250 mg

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

250 mg

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

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO VIDO NE K15 (UNII: E54VE15114)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

C10 -18 TRIGLYCERIDES (UNII: 43AGM4PHPI)

Product Characteristics

Color

WHITE (White)

S core

no sco re

S hap e

CAPSULE

S iz e

17mm

Flavor

Imprint Code

279 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55312-18 4-10

1 in 1 BOX

0 6 /19 /20 12

12/31/20 19

1

10 0 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 MONOGRAPH NOT FINAL part343

0 6 /19 /20 12

12/31/20 19

Labeler -

Western Family Foods, Inc. (192166072)

Revised: 12/2018

Similar products

Search alerts related to this product

Share this information