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  5. Label Information: Gravol Chewables Motion Sickness Dimenhydrinate

FDA Label for Gravol Chewables Motion Sickness Dimenhydrinate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU OR YOUR CHILD HAS
    7. WHEN USING THIS PRODUCT
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 50 MG BLISTER PACK CARTON

Gravol Chewables Motion Sickness Dimenhydrinate Product Label

The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - gravol 01

PRINCIPAL DISPLAY PANEL - 50 mg Blister Pack Carton - gravol 01


* Please review the disclaimer below.