Dramamine

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:19:12

Label at a glance#

ProductDramamine
Active ingredientDIMENHYDRINATE
Label structure13 sections

Dosage and administration

to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity to prevent or treat motion sickness, see below: Adults and children 12 years and over Take 1 to 2 chewable tablets every 4-6 hours Do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years Give 1/2 to 1 chewable tablet every 6-8 hours Do not give more than 3 chewable...

Storage and handling

Phenylketonurics: contains phenylalanine 0.84 mg per tablet. store at room temperature 68°-77°F (20°-25°C) do not use if packet is torn see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

DRUG FACTS

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dimenhydrinate 50 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Use

INDICATIONS & USAGE SECTION

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

  • nausea
  • vomiting
  • dizziness

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:
Adults and children 12 years and over
  • Take 1 to 2 chewable tablets every 4-6 hours
  • Do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years
  • Give 1/2 to 1 chewable tablet every 6-8 hours
  • Do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
Children 2 to under 6 years

Give 1/2 chewable tablet every 6-8 hours

Do not give more that 1 1/2 chewable tablets in 24 hours, or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet.
  • store at room temperature 68°-77°F (20°-25°C)
  • do not use if packet is torn
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, aspartame, FD&C yellow 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions?

OTC - QUESTIONS SECTION

1-800-382-7219 Dramamine.com

SPL UNCLASSIFIED SECTION

Dist. by Medtech Products Inc., Tarrytown, NY 10591
A Prestige Consumer Healthcare company. Made in Italy.
© 2021 Trade dress is owned by Medtech Products Inc.
All rights reserved.

PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Blister

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

Dramamine ®


motion sickness

CHEWABLE
Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting


4

Orange Flavored

Tablets (50 mg each)

PDPPDP

PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Blister

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

Dramamine ®


motion sickness

CHEWABLE
Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting


6

Orange Flavored Tablets (50 mg each)

DRAMAMINE 6CTDRAMAMINE 6CT

PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

Dramamine ®


motion sickness

CHEWABLE
Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting


25 POUCHES

2 Orange Flavored Tablets (50 mg each) per Pouch

PDPPDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-1216DRAMAMINE (DIMENHYDRINATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]8Legacy NDC20231207_cee22d00-e8a1-d735-e053-2995a90aec04.zip
29485-6925DRAMAMINE (DIMENHYDRINATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]8Legacy NDC20231207_cee22d00-e8a1-d735-e053-2995a90aec04.zip
29485-8048DRAMAMINE (DIMENHYDRINATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]8Legacy NDC20231207_cee22d00-e8a1-d735-e053-2995a90aec04.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29485-121629485-1216-2
29485-692529485-6925-3
29485-804829485-8048-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0bc9b688-9534-6bbc-e063-6294a90ac6a7cee22d00-e8a1-d735-e053-2995a90aec042023-12-05WarningsExact identifier
spl id: 0bc9b688-9534-6bbc-e063-6294a90ac6a7
spl set id: cee22d00-e8a1-d735-e053-2995a90aec04