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headache relief

Western Family Foods Inc

Western Family Headache Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteriodal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

headache relief Uses

  • 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 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

headache relief 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

Principal Display Panel

SEE NEW WARNINGS INFORMATION

Added Strength

Headache Relief

PAIN RELIEVER - PAIN RELIEVER AID

ACETAMINOPHEN, ASPIRIN (NSAID) and CAFFEINE

Gluten Free

COMPARE TO EXCEDRIN® active ingredients

headache relief
Headache Relief Carton Image 1 Headache Relief Carton Image 2

headache relief

Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-430
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
aspirin ASPIRIN 250 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CROSPOVIDONE
HYPROMELLOSES
cellulose, microcrystalline
povidone
propylene glycol
saccharin sodium
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 11 mm L430 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:55312-430-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2001-08-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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