Kids Gravol™ Chewables Motion Sickness Dimenhydrinate

Kids Gravol™ Chewables Motion Sickness Dimenhydrinate
SPL v1
SPL
SPL Set ID cf6de950-a157-4be2-a302-0dc19511d2f2
Route
ORAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (15 mg)
Inactive Ingredients
Diacetylated Monoglycerides Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer Aspartame Citric Acid Monohydrate Starch, Corn Ethylcellulose, Unspecified Magnesium Stearate Mannitol Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-30

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 4 to 6 tablets every 4 to 6 hours. Do not exceed 24 tablets in 24 hours, or as directed by a doctor
  • Children 6 to under 12 years of age: take 2 or 3 tablet every 6 to 8 hours. Do not exceed 10 tablets in 24 hours, or as directed by a doctor
  • Children 2 to under 6 years of age: give 1 tablet every 6-8 hours. Do not give more than 5 tablets in 24 hours, or as directed by a doctor
Active Ingredient

Dimenhydrinate 15 mg

Other Information
  • Phenylketonurics: contains phenylalanine 5 mg per tablet
  • Store between 59° - 77°F
Inactive Ingredients

acetylated monoglycerides, amino methacrylate copolymer, aspartame, cherry flavor, citric acid, corn starch, ethylcellulose, magnesium stearate, mannitol, microcrystalline cellulose, 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 15 Mg Blister Pack Carton

kids

Gravol™

MOTION SICKNESS

Dimenhydrinate tablets 15 mg

18

TABLETS

CHERRY

FLAVOR

DYE FREE


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 4 to 6 tablets every 4 to 6 hours. Do not exceed 24 tablets in 24 hours, or as directed by a doctor
  • Children 6 to under 12 years of age: take 2 or 3 tablet every 6 to 8 hours. Do not exceed 10 tablets in 24 hours, or as directed by a doctor
  • Children 2 to under 6 years of age: give 1 tablet every 6-8 hours. Do not give more than 5 tablets in 24 hours, or as directed by a doctor
Active Ingredient (Active ingredient)

Dimenhydrinate 15 mg

Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 5 mg per tablet
  • Store between 59° - 77°F
Inactive Ingredients (Inactive ingredients)

acetylated monoglycerides, amino methacrylate copolymer, aspartame, cherry flavor, citric acid, corn starch, ethylcellulose, magnesium stearate, mannitol, microcrystalline cellulose, 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 15 Mg Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 15 mg Blister Pack Carton)

kids

Gravol™

MOTION SICKNESS

Dimenhydrinate tablets 15 mg

18

TABLETS

CHERRY

FLAVOR

DYE FREE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)