Gravol™ Motion Sickness Relief - Coated Tablets

Gravol™ Motion Sickness Relief - Coated Tablets
SPL v3
SPL
SPL Set ID d95240bb-02f2-3226-e053-2995a90afacd
Route
ORAL
Published
Effective Date 2022-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Ferric Oxide Yellow Magnesium Stearate Silicon Dioxide Talc Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Titanium Dioxide Croscarmellose Starch, Corn Lactose Monohydrate Microcrystalline Cellulose Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Shape: round Color: orange Size: 8 mm Score: 4
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-02

Description

Dimenhydrinate 50 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Dimenhydrinate 50 mg

Use

For prevention and treatment of these symptoms associated with motion sickness:

  • nausea

  • vomiting

  • dizziness
Directions
  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:
adults and children 12 years and over:
  • take 1 to 2 tablets every 4-6 hours
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years:
  • give 1/2 to 1 tablet every 6-8 hours
  • do not give more than 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years:
  • give 1/4 to 1/2 tablet every 6-8 hours
  • do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor

Do Not Use

for children under 2 years of age unless directed by a doctor.

Other Information
  • store at room temperature 59º-77ºF (15º-25ºC)
  • do not use if packet is torn
Inactive Ingredients

Corn starch, croscarmellose sodium, FD&C yellow 6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

1-800-952-5080 M-F 9am to 5pm ET

Principal Display Panel

OVER 70 YEARS OF

QUALITY & TRUST†

Prevents and Treats:

Nausea & Vomiting

Dizziness*

*Prevention and treatment of nausea,

vomiting and dizziness due to motion sickness

Gravol™ COATED TABLETS

Gravol™

MOTION SICKNESS RELIEF

Dimenhydrinate 50 mg Tablets - Antiemetic

10

COATED TABLETS

TASTE FREE

EASY TO SWALLOW

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase dizziness
  • be careful when driving a motor vehicle or operating machinery or any activity that requires alertness
If Pregnant Or Breast Feeding,

ask a doctor before use.

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.

Active Ingredient (in Each Tablet)

Dimenhydrinate 50 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking

sedatives or tranquilizers


Structured Label Content

Use

For prevention and treatment of these symptoms associated with motion sickness:

  • nausea

  • vomiting

  • dizziness
Purpose

Antiemetic

Directions
  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:
adults and children 12 years and over:
  • take 1 to 2 tablets every 4-6 hours
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years:
  • give 1/2 to 1 tablet every 6-8 hours
  • do not give more than 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years:
  • give 1/4 to 1/2 tablet every 6-8 hours
  • do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor

Do Not Use (Do not use)

for children under 2 years of age unless directed by a doctor.

Other Information (Other information)
  • store at room temperature 59º-77ºF (15º-25ºC)
  • do not use if packet is torn
Inactive Ingredients (Inactive ingredients)

Corn starch, croscarmellose sodium, FD&C yellow 6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-952-5080 M-F 9am to 5pm ET

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

OVER 70 YEARS OF

QUALITY & TRUST†

Prevents and Treats:

Nausea & Vomiting

Dizziness*

*Prevention and treatment of nausea,

vomiting and dizziness due to motion sickness

Gravol™ COATED TABLETS

Gravol™

MOTION SICKNESS RELIEF

Dimenhydrinate 50 mg Tablets - Antiemetic

10

COATED TABLETS

TASTE FREE

EASY TO SWALLOW

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase dizziness
  • be careful when driving a motor vehicle or operating machinery or any activity that requires alertness
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Dimenhydrinate 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)

sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)