Label: PHYSICIANS CARE IBUPROFEN- ibuprofen 200mg tablet, coated
- NDC Code(s): 0924-0075-00, 0924-0075-01, 0924-0075-02, 0924-0075-03
- Packager: Acme United Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Allergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may
include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blisters
If an allergic reaction occurs, stop use and seek medical help right away.
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
Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
- DO NOT USE
-
ASK DOCTOR
Ask a doctor before use if
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ 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, kidney disease, asthma or had a stroke
■ you are taking a diuretic
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor 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
■ you have symptoms of heart problems or stroke
■ chest pain ■ trouble breathing ■ leg swelling ■ weakness in one part or side of body ■ slurred speech
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ redness or swelling is present in the painful area
■ any new or unexpected symptoms occur
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
■ do not use more than directed
■ the smallest effective dose should be used
■ do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children:(12 years and older)
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 :
Do not give to children under 12 years of age.
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive ingredients
carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*,
microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*,
silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide
*may contain
- Physicians Care Ibuprofen Label
-
INGREDIENTS AND APPEARANCE
PHYSICIANS CARE IBUPROFEN
ibuprofen 200mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0075 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0075-01 50 in 1 CARTON 02/01/2016 1 NDC:0924-0075-00 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-0075-03 10 in 1 CARTON 02/01/2016 2 NDC:0924-0075-00 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-0075-02 125 in 1 CARTON 02/01/2016 3 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 02/01/2016 Labeler - Acme United Corporation (001180207)