Label: MECLIZINE HCL 25 MG- meclizine hcl tablet
- NDC Code(s): 68788-7982-1, 68788-7982-3
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 69618-028
- 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 November 15, 2022
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)
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this prodcut
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.
Repackaged By: Preferred Pharmaceuticals Inc.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7982(NDC:69618-028) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) RASPBERRY (UNII: 4N14V5R27W) ASPARTAME (UNII: Z0H242BBR1) SUCROSE (UNII: C151H8M554) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color pink (Light Raspberry color) Score 2 pieces Shape ROUND Size 8mm Flavor RASPBERRY Imprint Code AP;115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7982-1 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2021 2 NDC:68788-7982-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 07/28/2021 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-7982)