Label: MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable
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NDC Code(s):
71335-9751-0,
71335-9751-1,
71335-9751-2,
71335-9751-3, view more71335-9751-4, 71335-9751-5, 71335-9751-6, 71335-9751-7, 71335-9751-8, 71335-9751-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 16571-824
- 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 July 19, 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 chewable tablet)
- Purpose
- Uses
- Warnings
- ASK DOCTOR/PHARMACIST
- When using this product
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients
- Questions or comments?
- TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH"SEALED for YOUR PROTECTION" IS BROKEN OR MISSING.Rising Pharma Holdings, Inc. is not affiliated with the owner of the registered trademark Bonine® Manufactured by: Unique Pharmaceutical Laboratories(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.),Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc.East Brunswick, NJ 08816 Mfg. Lic. No.: G/1430Feb 2022
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HOW SUPPLIED
NDC: 71335-9751-1: 30 Tablets in a BOTTLE
NDC: 71335-9751-2: 20 Tablets in a BOTTLE
NDC: 71335-9751-3: 25 Tablets in a BOTTLE
NDC: 71335-9751-4: 40 Tablets in a BOTTLE
NDC: 71335-9751-5: 60 Tablets in a BOTTLE
NDC: 71335-9751-6: 90 Tablets in a BOTTLE
NDC: 71335-9751-7: 8 Tablets in a BOTTLE
NDC: 71335-9751-8: 14 Tablets in a BOTTLE
NDC: 71335-9751-9: 10 Tablets in a BOTTLE
NDC: 71335-9751-0: 120 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MECLIZINE HCL
meclizine hydrochloride chewable tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-9751(NDC:16571-824) 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 ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) RASPBERRY (UNII: 4N14V5R27W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color pink (Pink to light pink) Score 2 pieces Shape ROUND Size 8mm Flavor RASPBERRY Imprint Code M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-9751-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 2 NDC:71335-9751-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 3 NDC:71335-9751-3 25 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 4 NDC:71335-9751-4 40 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 5 NDC:71335-9751-5 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 6 NDC:71335-9751-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 7 NDC:71335-9751-7 8 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 8 NDC:71335-9751-8 14 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 9 NDC:71335-9751-9 10 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 10 NDC:71335-9751-0 120 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/18/2022 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-9751) , RELABEL(71335-9751)