Gravol Chewables Motion Sickness Dimenhydrinate Tablet, Chewable
FDA Label NDC 10237-943

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Gravol Chewables Motion Sickness Dimenhydrinate (NDC 10237-943). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, ask a doctor before use if you or your child has, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Dimenhydrinate 50 mg

Purpose

antiemetic

Uses

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

Otc - Do Not Use

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

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

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

Questions Or Comments?

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

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

Principal Display Panel (50 mg Blister Pack Carton)

Principal Display Panel (50 mg Blister Pack Carton)

* Please review the disclaimer below.