MEDIQUE ASPIRN tablet, film coated

MEDIQUE ASPIRN by

Drug Labeling and Warnings

MEDIQUE ASPIRN by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin (NSAID*) 325mg *nonsteroidal anti-inflammatory drug

PURPOSE

Pain Reliever/Fever Reducer

WHEN USING

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, skin reddening, facial swelling, rash, asthma (wheezing), blisters or shock. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: this 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 thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks everyday while using this problem, take more for a longer time than directed.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery, if you are taking a prescription drug for gout, diabetes or arthritis.

Ask a doctor before use if: 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.

Ask a Doctor or Pharmacist before use if you are: under a doctor's care for any serious condition, taking any other drug.

When using this product: take with food or milk if stomach upset occurs

Stop use and Ask a Doctor if: you experience any of the following signs of stomach bleeding, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.

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

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

DIRECTIONS

Do not use more than directed - the smallest effective dosage should be used. Drink a full glass of water with each dose. Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours or as directed as a doctor.

Children under 12 years: Do not give to children under 12 years of age

Avoid excessive heat and humidity, do not use any open or torn packets.

USE

Temporarily relieves minor aches and pains associated with: headache, muscular aches, minor arthritis pain, backache, common cold, toothache, menstrual cramps, temporarily reduces fever.

ASK DOCTOR

Ask a doctor before use if: 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.

Ask a Doctor or Pharmacist before use if you are: under a doctor's care for any serious condition, taking any other drug.

STOP USE

Stop use and Ask a Doctor if: you experience any of the following signs of stomach bleeding, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

DO NOT USE

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery, if you are taking a prescription drug for gout, diabetes or arthritis.

HOW SUPPLIED

1 (2 Pack) 325 MG Packet

DOSAGE & ADMINISTRATION

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours or as directed as a doctor.

INDICATIONS & USAGE

Pain Reliever/Fever Reducer

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, skin reddening, facial swelling, rash, asthma (wheezing), blisters or shock. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: this 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 thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks everyday while using this problem, take more for a longer time than directed.

WARNINGS

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery, if you are taking a prescription drug for gout, diabetes or arthritis.

Ask a doctor before use if: 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.

Ask a Doctor or Pharmacist before use if you are: under a doctor's care for any serious condition, taking any other drug.

When using this product: take with food or milk if stomach upset occurs

Stop use and Ask a Doctor if: you experience any of the following signs of stomach bleeding, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.

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

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

Do not use more than directed - the smallest effective dosage should be used. Drink a full glass of water with each dose. Do not take longer than 10 days, unless directed by a doctor.

INACTIVE INGREDIENT

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINERAL OIL (UNII: T5L8T28FGP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDIQUE ASPIRN 
medique aspirn tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1277(NDC:47682-097)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1277-2	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/30/2008

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	relabel(51662-1277)