Label: MOTION-TIME CHEWABLE- meclizine hcl tablet, chewable
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NDC Code(s):
71335-0821-0,
71335-0821-1,
71335-0821-2,
71335-0821-3, view more71335-0821-4, 71335-0821-5, 71335-0821-6, 71335-0821-7, 71335-0821-8, 71335-0821-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 49483-333
- Category: HUMAN OTC DRUG LABEL
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 January 19, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- DO NOT USE
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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HOW SUPPLIED
Product: 71335-0821
NDC: 71335-0821-0 120 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-1 30 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-2 20 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-3 25 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-4 40 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-5 60 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-6 90 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-7 8 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-8 14 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0821-9 10 TABLET, CHEWABLE in a BOTTLE
- Meclizine 25MG Chewable
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INGREDIENTS AND APPEARANCE
MOTION-TIME CHEWABLE
meclizine hcl tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0821(NDC:49483-333) 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 in 25 Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) RASPBERRY (UNII: 4N14V5R27W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) VANILLA (UNII: Q74T35078H) Product Characteristics Color pink Score 2 pieces Shape ROUND Size 9mm Flavor RASPBERRY Imprint Code TCL333 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0821-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 2 NDC:71335-0821-4 40 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 3 NDC:71335-0821-7 8 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 4 NDC:71335-0821-5 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 5 NDC:71335-0821-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 6 NDC:71335-0821-8 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 7 NDC:71335-0821-3 25 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 8 NDC:71335-0821-9 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 9 NDC:71335-0821-0 120 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 10 NDC:71335-0821-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/09/2010 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0821) , RELABEL(71335-0821)