HEADACHE RELIEF ADDED STRENGTH acetaminophen aspirin caffeine tablet film coated

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Medicine Shoppe International Inc
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 250 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

HEADACHE RELIEF ADDED STRENGTH- acetaminophen, aspirin, caffeine tablet, film

coated

Medicine Shoppe International 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.

----------

Medicine Shoppe International, Inc. Headache Relief Drug Facts

Active ingredient (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteriodal anti-inflammatory drug

Purpos e

Pain reliever

Pain reliever aid

Us es

temporarily relieves minor aches and pains due to:

headache

muscular aches

sinusitis

arthritis

a cold

toothache

premenstrual and 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 tablets 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

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

When using this product

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 any other pain reliever/fever reducer

if you are allergic to aspirin

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

arthritis

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

redness or swelling is present

any new symptoms occur

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

ringing in the ears or a loss of hearing occurs

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. (1-800-222-1222)

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 Liver warning)

drink a full glass of water with each dose

adults and children 12 years and over: take 2 tablets every 6 hours; do not exceed 8 tablets in 24

hours

children under 12 years: ask a doctor

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, crospovidone, FD&C blue no. 1 lake, hypromellose, microcrystalline cellulose**,

povidone, propylene glycol, saccharin sodium, starch, stearic acid, titanium dioxide **may contain this

ingredient

Questions or comments? 1-800-719-9260

Principal Display Panel

ADDED STRENGTH

See New Warnings Information

HEADACHE RELIEF

Pain Reliever/Pain Reliever Aid

Acetaminophen, Aspirin (NSAID) and Caffeine

COMPARE TO EXCEDRIN® EXTRA STRENGTH active ingredients

Headache Relief Carton Imag e 1

Headache Relief Carton Imag e 2

HEADACHE RELIEF ADDED STRENGTH

acetaminophen, aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 6 14-114

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

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

L430

Contains

Medicine Shoppe International Inc

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 6 14-114-78

1 in 1 CARTON

1

10 0 in 1 BOTTLE

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 4/0 9 /19 9 2

Labeler -

Medicine Shoppe International Inc (071997654)

Revised: 6/2009

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