Gravol™

Gravol™
SPL v4
SPL
SPL Set ID d941705f-12a1-4757-e053-2995a90ad3fa
Route
ORAL
Published
Effective Date 2024-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Water D&c Red No. 33 Sorbitol Sorbitan Povidone, Unspecified

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: pink Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-02

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) rtght away.

Section 50568-5

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

Section 50569-3

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
Section 50570-1

Do not use for children under 6 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 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
Active Ingredient

Dimenhydrinate 50 mg

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

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
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


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) rtght away.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use for children under 6 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 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
Active Ingredient (Active ingredient)

Dimenhydrinate 50 mg

Other Information

Store between 59° – 77°F

Inactive Ingredients (Inactive ingredients)

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

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
Principal Display Panel 50 Mg Capsule Blister Pack Carton (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)