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NDC 00363-0198-08 Wal-Dram 50 mg/1 Details

Wal-Dram 50 mg/1

Wal-Dram is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0198-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dimenhydrinate

Product Information

NDC	00363-0198
Product ID	0363-0198_0fc5ad4d-3bb4-4122-a7f8-9ec23683cba7
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	Wal-Dram
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	Walgreen Company
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0198-08 (00363019808)

Pricing Information	N/A
NDC Package Code	0363-0198-08
Billing NDC	00363019808
Package	4 BLISTER PACK in 1 CARTON (0363-0198-08) / 6 TABLET in 1 BLISTER PACK
Marketing Start Date	1992-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a0af458b-86fe-424c-9067-d14b09491c5a Details

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

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

nausea
vomiting
dizziness

Warnings

Do not use

for children under 2 years of age unless directed by a doctor.

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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 beverages
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 first dose should be taken one-half to one hour before starting activity

adults and children 12 years and over	1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years	½ to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years	½ tablet every 6-8 hours; do not exceed 1½ tablets in 24 hours, or as directed by a doctor

Other information

each tablet contains: calcium 35 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from moisture
see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Dramamine®

original formula active ingredient††

NDC 0363-0198-08

Wal-Dram®

DIMENHYDRINATE TABLETS, 50 mg / ANTIEMETIC

• For children & adults

• Prevents nausea, dizziness & vomiting

24 TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com ©2017 Walgreen Co.

††This product is not manufactured or distributed by Medtech Products Inc.,

owner of the registered trademark Dramamine® Original Formula.

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

50844 REV0518B19808

Walgreens 44-198

INGREDIENTS AND APPEARANCE

WAL-DRAM

dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0198
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, 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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;198
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0198-08	4 in 1 CARTON	12/01/1992	10/22/2023
1		6 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	12/01/1992	10/22/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-0198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0198)

Revised: 3/2022

Document Id: 0fc5ad4d-3bb4-4122-a7f8-9ec23683cba7

Set id: a0af458b-86fe-424c-9067-d14b09491c5a

Version: 27

Effective Time: 20220302