FDA Label for Exaprin-ac
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Exaprin-ac Product Label
The following document was submitted to the FDA by the labeler of this product Hart Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each caplet)
Aspirin (NSAID*) 500 mg *nonsteroidal anti-inflammatory drug
Caffeine 32.5 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Pain reliever aid
Indications & Usage
Uses
for the temporary relief of minor aches and pains due to
■ headache
■ muscular aches
■ backache pain
■ minor arthritis pain
■ common cold
■ toothache
■ menstrual cramps
Temporarily reduces fever
Warnings
Warnings
Reye's syndrome:
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with salicylates.
Allergy alert:
Magnesium salicylate may cause a severe allergic reaction which may include:
■ hives
■ facial swelling
■ asthma (wheezing)
■ shock
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
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to any pain reliever/fever reducer.
Otc - 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 asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ you are taking a diuretic
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you take any drug for diabetes, gout or arthritis
Otc - Stop Use
Stop use and ask a doctor if
■ an allergic reaction occurs, seek medical help right away
■ fever worsens or lasts more than 3 days
■ pain worsens or lasts more than 10 days
■ you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - 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. 1-800-222-1222
Dosage & Administration
Directions
Do not take more than directed.
Adults and children 12 years of age and over:
■ take 2 caplets with a full glass of water every 6 hours while symptoms persist
■ do not take more than 8 caplets in 24 hours unless directed by a doctor
Children under 12 years: ask a doctor
Other Safety Information
Other information
■ caplets enclosed in a sealed packet
■ do not use if packet is torn, cut or open
■ store at 59° to 86°F (15°-30°C)
■ avoid excessive heat and humidity
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate
Package Label.Principal Display Panel
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