Drug Facts
Active Ingredient (in each tablet)
Dimenhydrinate 50 mg
Dimenhydrinate
FDA Label NDC 0924-1007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Dimenhydrinate (NDC 0924-1007). 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 drug facts, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiemetic
Uses
for prevention and treatment of nausea, vomiting or dizziness associated with motion sickness
Otc - Do Not Use
Do not use in children under 2 years of age unless directed by a doctor
Otc - Ask Doctor
Ask doctor before use if you have
- breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland.
Otc - Ask Doctor/Pharmacist
Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
When using this product
- marked drowsiness may occir
- avoid alcoholic drinks
- alcohol, sedatives and traquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a helath professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact Poison Control Center (800-222-1222) right away.
Directions
To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.
To prevent or treat motion sickness:
| Adults and Children (12 years and older) | take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor. |
| Children 6 to under 12 years | give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor. |
| Children 2 to under 6 years | give ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor |
Other Information
- each tablet contains calcium 29 mg
- store at room temperature
- do not use if packet is open or torn
Inactive Ingredient
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose
Questions?
1-800-835-2263
Other
Retain carton for complete product information
Manufactured for:
Acme United Corporation
55 Walls Dr, Fairfield, CT 06824
www.FirstAidOnly.com
Made in the USA
©2018 Acme United Corporation
Package Label.Principal Display Panel
Physician Care®
Motion Sickness
Dimenhydrinate/ Antiemetic
Nausea, Vomiting and Dizziness Relief
Tamper-Evident Packets of 2 Tablets
Do not use if packet is open or torn.
Dimenhydrinate 50mg
100 Tablets (50 Packets, 2 Tablets each)
* Please review the disclaimer below.
