Drug Facts

Sina Health Inc

Dosage Form

N/A

Manufacturer

Sina Health Inc

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

Temporarily relieves minor aches and pains associated with

headache
minor arthritis pain
common cold
menstrual cramps
muscular aches
backache
toothache

Temporarily reduces fever.

take with food or milk if stomach upset occurs

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

70385-2005-2

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

hives
skin reddening
facial swelling
rash
asthma (wheezing)
blisters
shock

If an allergic reaction occurs, stop use and seek medical help right away.

SPL UNCLASSIFIED SECTION

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 alcohol drinks every day while using this product
take more or for a longer time than directed

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Other information

read all product information before using
store at room temperature 59º-86ºF (15º-30ºC)
avoid excessive heat and humidity
tamper evident sealed packets
do not use any opened or torn packets

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Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose

Do not use if…Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if…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 pain gets worse or lasts more than 10 days fever gets worse or…

Ask a doctor or pharmacist before use if…under a doctor's care for any serious condition taking any other drug

Stop use and talk to a doctor if…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 prescription drugs for gout, diabetes or arthritis

Package label

What it looks like

Package codes (NDC)

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Other information

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