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NDC 00904-6772-12 Dimenhydrinate 50 mg/1 Details

Dimenhydrinate 50 mg/1

Dimenhydrinate is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is DIMENHYDRINATE.

MedlinePlus Drug Summary

Dimenhydrinate is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. Dimenhydrinate is in a class of medications called antihistamines. It works by preventing problems with body balance.

Related Packages: 00904-6772-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dimenhydrinate

Product Information

NDC	00904-6772
Product ID	0904-6772_b4043aed-f29f-c266-e053-2995a90a1c58
Associated GPIs	50200030000310
GCN Sequence Number	004720
GCN Sequence Number Description	dimenhydrinate TABLET 50 MG ORAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	18231
HICL Sequence Number	004603
HICL Sequence Number Description	DIMENHYDRINATE
Brand/Generic	Generic
Proprietary Name	Dimenhydrinate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimenhydrinate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DIMENHYDRINATE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-6772-12 (00904677212)

Pricing Information
NDC Package Code	0904-6772-12
Billing NDC	00904677212
Package	1 BLISTER PACK in 1 CARTON (0904-6772-12) / 12 TABLET in 1 BLISTER PACK
Marketing Start Date	2019-02-14
NDC Exclude Flag	N
Price Per Unit	0.0718
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	DRIMINATE 50 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 78d22836-a442-7c0c-e053-2991aa0a62f3 Details

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

SPL UNCLASSIFIED SECTION

Purpose

Antiemetic

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

SPL UNCLASSIFIED SECTION

Do not give to 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

■ trouble urinating due to an enlarged 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

■ use caution 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 (1-800-222-1222) right away.

Directions

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity

■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor

■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor

■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information

■ each tablet contains: calcium 29 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ protect from moisture

■ see end -ap for expiration date and lot number

■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

SPL UNCLASSIFIED SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-616-2471

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Tablets.

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC 0904-6772-12

Compare to the Active Ingredient in DRAMAMINE ® Original Formula*

Driminate TM

Dimenhydrinate USP, Antiemetic

For Nausea, Dizziness and Vomiting from Motion Sickness

12 Tablets 50mg Each

Use as Directed

INGREDIENTS AND APPEARANCE

DIMENHYDRINATE

dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6772
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	1006;1006
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6772-12	1 in 1 CARTON	02/14/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	02/14/2019

Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2020

Document Id: b4043aed-f29f-c266-e053-2995a90a1c58

Set id: 78d22836-a442-7c0c-e053-2991aa0a62f3

Version: 2

Effective Time: 20201113

Search by Drug Name or NDC

NDC 00904-6772-12 Dimenhydrinate 50 mg/1 Details

Dimenhydrinate 50 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00904-6772-12 (00904677212)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 78d22836-a442-7c0c-e053-2991aa0a62f3 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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