Label: DRAMAMINE- dimenhydrinate tablet
- NDC Code(s): 67751-170-01, 67751-170-02
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 63029-901
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Use
-
Warnings
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 -
Directions
to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
to prevent or treat motion sickness:adults and children 12 years and over • take 1 to 2 chewable tablets every 4-6 hours
• do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years • give 1/2 to 1 chewable tablet every 6-8 hours
• do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years • give 1/2 chewable tablet every 6-8 hours
• do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
DRAMAMINE
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-170(NDC:63029-901) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score 2 pieces Shape ROUND Size 8mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-170-01 1 in 1 CARTON 09/23/2016 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-170-02 1 in 1 CARTON 09/23/2016 2 4 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 09/23/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-170) , repack(67751-170)
