IBUPROFEN: Package Insert and Label Information
IBUPROFEN- ibuprofen tablet, film coated
ADVANCED FIRST AID, INC.
ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)
pain reliever/fever reducer
Uses:
temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • temporarily reduces fever
Warnings:
Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
• hives • facial swelling • asthma (wheezing) • shock • skin reddening • blisters If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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.
Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
Ask a doctor use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain •
ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older
Ask a doctor or pharmacist before use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • 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 • long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if: • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically 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.
Directions:
Adults and children 12 years of age and older:
• do not take more than directed • the smallest effective dose should be used • take 1 tablet every 4 to 6 hours while symptoms
persist. • If pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years of age: do not use for children under 12 years of age unless directed by a doctor.
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelantinized starch, talc, titanium dioxide.
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| Labeler — ADVANCED FIRST AID, INC. (114477180) |
| Registrant — ADVANCED FIRST AID, INC. (114477180) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| ULTRA SEAL CORPORATION | 085752004 | pack (67060-750) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| SHAUN PHARMACEUTICALS LIMITED | 915786829 | manufacture (67060-750) | |
Revised: 10/2019 ADVANCED FIRST AID, INC.
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