NDC | 64380-732-11, 64380-732-12, 64380-732-13, 64380-732-14, 64380-732-15, 64380-732-18, 64380-732-19, 64380-732-20, 64380-732-29 |
Set ID | 10d52858-a55f-4053-aa77-da660556a2ad |
Category | HUMAN OTC DRUG LABEL |
Packager | Strides Shasun Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA200888 |
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
-
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
- rash
- 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
-
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- unless you have time for a full night's sleep
- in children under 12 years of age
- right before or after heart surgery
- with any other product containing diphenhydramine, even one used on skin
- if you have sleeplessness without pain
-
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke.
- you are taking a diuretic
- you have a breathing problem such as emphysema or chronic bronchitis
- you have glaucoma
- you have trouble urinating due to an enlarged prostate gland
- Ask doctor or pharmacist before use if you are
- When using this product
-
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
• weakness in one part or side of body
• slurred speech
• leg swelling
• pain gets worse or lasts more than 10 days
• Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear
- If pregnant or breast feeding
- Keep out of reach of children
-
DIRECTIONS
- do not take more than directed
- adults and children 12 years and over: take 2 capsules at bedtime
- do not take more than 2 capsules in 24 hours
• each capsule contains: potassium 20 mg
• read all warnings and directions before use. Keep carton.
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light
-
INACTIVE INGREDIENT
Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.
Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN AND DIPHENHYDRAMINE HCL
ibuprofen and diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64380-732 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) Product Characteristics Color PURPLE (Bluish purple color) Score no score Shape OVAL Size 16mm Flavor Imprint Code 1007 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64380-732-14 2 in 1 CARTON 03/05/2012 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:64380-732-15 4 in 1 CARTON 03/05/2012 2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:64380-732-20 24 in 1 BOX 03/05/2012 3 NDC:64380-732-19 24 in 1 CARTON 3 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:64380-732-29 1 in 1 CARTON 12/28/2016 4 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:64380-732-12 1 in 1 CARTON 12/28/2016 5 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:64380-732-13 1 in 1 CARTON 12/28/2016 6 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 7 NDC:64380-732-11 1 in 1 CARTON 12/28/2016 7 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 8 NDC:64380-732-18 1 in 1 CARTON 12/28/2016 8 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200888 03/05/2012 Labeler - Strides Shasun Limited (650738743) Registrant - Strides Shasun Limited (650738743) Establishment Name Address ID/FEI Business Operations Strides Shasun Limited 918513263 ANALYSIS(64380-732) , MANUFACTURE(64380-732)