DIMENHYDRINATE- dimenhydrinate tablet 
Qualitest Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dimenhydrinate Tablets, USP 50mg

Drug Facts

.

Active Ingredient

(in each tablet)

Dimenhydrinate USP, 50 mg

Purpose

Antiemetic

Uses

For prevention and treatment of these symptoms associated with motion sickness:

  • Nausea
  • Vomiting
  • diziness

WARNINGS

Do not use in children under 2 years of age unless directed by a doctor

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

if pregnant or breast-feeding, ask a health professional before use,

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222).

Directions

  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, use the following dosing
     Adults and children 12 years and over 1-2 tablets every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor 
     Children 6 years to under 12 years ½-1 tablet every 6 – 8 hours, not more than 3 tablets in 24 hours, or as directed by a doctor 
     Children 2 years to under 6 years ¼- ½ tablet every 6-8 hours, not more than 11/2 tablets in 24 hours, or as directed by a doctor

Other Information

  • store at 15-30 °C (59-86 °F)
  • you may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients

Crosscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC 0603-3330-21 (100 Tablets)

NDC 0603-3330-32 (1000 Tablets)

DIMENHYDRINATE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-3330
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScorescore with uneven pieces
ShapeROUNDSize9mm
FlavorImprint Code 130
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-3330-21100 in 1 BOTTLE; Type 0: Not a Combination Product06/05/201512/31/2017
2NDC:0603-3330-321000 in 1 BOTTLE; Type 0: Not a Combination Product06/05/201512/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33606/05/201512/31/2017
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical, Inc.078301063MANUFACTURE(0603-3330)

Revised: 6/2015
 
Qualitest Pharmaceuticals