Gravol™ Chewables Motion Sickness Dimenhydrinate

Gravol™ Chewables Motion Sickness Dimenhydrinate
SPL v1
SPL
SPL Set ID de5249f7-79fc-4f3c-965a-1e8ec978a0b7
Route
ORAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Diacetylated Monoglycerides Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer Aspartame Citric Acid Monohydrate Starch, Corn Ethylcellulose (10 Mpa.s) Fd&c Yellow No. 6 Magnesium Stearate Mannitol Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Shape: round Color: orange Size: 14 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01
Description

Drug Facts

Purpose

antiemetic

Medication Information

Purpose

antiemetic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50570-1

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

Section 53414-9

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

Directions

To prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity

  • Adults and children 12 years of age and older: take 1 to 2 tablets every 4 to 6 hours. Do not exceed 8 tablets in 24 hours, or as directed by a doctor
  • Children 6 to under 12 years of age: take ½ to 1 tablet every 6 to 8 hours. Do not exceed 3 tablets in 24 hours, or as directed by a doctor
  • Children 2 to under 6 years of age: give ½ tablet every 6-8 hours. Do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor
Active Ingredient

Dimenhydrinate 50 mg

Other Information
  • Phenylketunurics: contains phenylalanine 15 mg per tablet
  • Store between 59° - 77°F
Inactive Ingredients

acetylated monoglycendes, amino methacrylate copolymer, aspartame, citric acid, com starch, ethylcellulose, FD&C yellow 6 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, polyethylene glycol

Questions Or Comments?

Call us at 1-888-334--5387 M-F 9am-5pm ET

When Using This Product
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Or Your Child Has
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you or your child is taking a sedative or tranquilizer

Principal Display Panel 50 Mg Blister Pack Carton

Prevents and Treats:

Nausea, Vomiting

& Dizziness*

*Prevention and treatment of nausea,

vomiting and dizziness due to motion sickness

Gravol™ CHEWABLES

Gravol™

MOTION SICKNESS

Dimenhydrinate tablets 50 mg

8

TABLETS

ORANGE

FLAVOR

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

antiemetic

Directions

To prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity

  • Adults and children 12 years of age and older: take 1 to 2 tablets every 4 to 6 hours. Do not exceed 8 tablets in 24 hours, or as directed by a doctor
  • Children 6 to under 12 years of age: take ½ to 1 tablet every 6 to 8 hours. Do not exceed 3 tablets in 24 hours, or as directed by a doctor
  • Children 2 to under 6 years of age: give ½ tablet every 6-8 hours. Do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor
Active Ingredient (Active ingredient)

Dimenhydrinate 50 mg

Other Information (Other information)
  • Phenylketunurics: contains phenylalanine 15 mg per tablet
  • Store between 59° - 77°F
Inactive Ingredients (Inactive ingredients)

acetylated monoglycendes, amino methacrylate copolymer, aspartame, citric acid, com starch, ethylcellulose, FD&C yellow 6 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, polyethylene glycol

Questions Or Comments? (Questions or comments?)

Call us at 1-888-334--5387 M-F 9am-5pm ET

When Using This Product (When using this product)
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Or Your Child Has (Ask a doctor before use if you or your child has)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you or your child is taking a sedative or tranquilizer

Principal Display Panel 50 Mg Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 50 mg Blister Pack Carton)

Prevents and Treats:

Nausea, Vomiting

& Dizziness*

*Prevention and treatment of nausea,

vomiting and dizziness due to motion sickness

Gravol™ CHEWABLES

Gravol™

MOTION SICKNESS

Dimenhydrinate tablets 50 mg

8

TABLETS

ORANGE

FLAVOR

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:54.877854 · Updated: 2026-03-14T23:02:43.906306