Label: MECLIZINE- meclizine hcl 12.5 mg tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 50090-3017-3, 50090-3017-7, 50090-3017-8 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 16103-386
- 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 May 12, 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 (in each caplet)
- Purpose
- Uses
-
Warnings
Do not use for children under 12 years of age unless directed by a doctor.
Do not take unless directed by a doctor if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.
- Directions
- Other information
- Inactive ingredients
- Questions?
- HOW SUPPLIED
- Meclizine HCl 12.5 mg
-
INGREDIENTS AND APPEARANCE
MECLIZINE
meclizine hcl 12.5 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3017(NDC:16103-386) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE (CAPSULE SHAPED TABLET) Size 13mm Flavor Imprint Code PH049 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3017-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 2 NDC:50090-3017-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 3 NDC:50090-3017-8 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 02/01/2018 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3017) , REPACK(50090-3017)