Gravol Capsule, Liquid Filled
FDA Label NDC 10237-940

15 label sections · Submitted to the FDA by Church & Dwight Co., Inc. · 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 (NDC 10237-940). 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, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, 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 6 years of age, unless directed by a doctor

Otc - Ask 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

Otc - Ask Doctor/Pharmacist

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) rtght away.

Directions

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

  • Adults and children 12 years of age and older: take 1 or 2 capsules every 4 to 6 hours. Do not exceed 8 capsules in 24 hours, or as directed by a doctor
  • Children 6 to under 12 years of age: take 1 capsule every 6 to 8 hours. Do not exceed 3 capsules in 24 hours, or as directed by a doctor

Other Information

Store between 59° – 77°F

Inactive Ingredients

D&C red 33, gelatin, glycerin, polyethylene glycol 400, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

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

Principal Display Panel - 50 Mg Capsule Blister Pack Carton

Gravol™
MOTION SICKNESS
Dimenhydrinate capsules 50 mg

24
LIQUID GELS
(Liquid Filled
Capsules)

TASTE FREE
EASY TO SWALLOW

Principal Display Panel (50 mg Capsule Blister Pack Carton)

Principal Display Panel (50 mg Capsule Blister Pack Carton)

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