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
Purpose

antiemetic

Description

Drug Facts

Medication Information

Uses

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

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
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

Description

Drug Facts

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.

Active Ingredient

Dimenhydrinate 50 mg

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

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
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

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.

Active Ingredient (Active ingredient)

Dimenhydrinate 50 mg

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