Label: IBUPROFEN tablet, film coated
- NDC Code(s): 37808-393-12, 37808-393-13, 37808-393-20
- Packager: H E B
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each orange caplet)
- Purpose
- Uses
-
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- rash
- blisters
- hives
- facial swelling
- shock
- asthma (wheezing)
- skin reddening
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 and 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
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
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
- weakness in one part or side of body
- slurred speech
- trouble breathing
- leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
-
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to Motrin® IB Caplets active ingredient†
NDC 37808-393-12
H-E-B®
Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer
(NSAID)For Body Aches and Pains
actual size
100 COATED CAPLETS**
**Capsule-Shaped Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING† This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Motrin® IB Caplets. 50844 REV1221B39312
MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204100%
GUARANTEE
promiseIf you aren't completely
pleased with this product,
we'll be happy to replace it
or refund your money.
You have our word on it.
HEB 44-393
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-393 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL Size 14mm Flavor Imprint Code 44;393 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-393-12 1 in 1 CARTON 03/01/1999 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:37808-393-13 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/1999 3 NDC:37808-393-20 225 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/1999 10/25/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 03/01/1999 Labeler - H E B (007924756) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(37808-393) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(37808-393) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(37808-393) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(37808-393) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(37808-393) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(37808-393)