Label: MECLIZINE HCL 12.5 MG tablet
- NDC Code(s): 68788-6956-1, 68788-6956-3
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 69618-027
- 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.
Updated July 16, 2020
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- Drug Facts
- Active indredient (in each caplet)
Ask a docotor 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 product
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquillizers 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
Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580
Repackaged By: Preferred Pharmaceuticals Inc.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MECLIZINE HCL 12.5 MG
meclizine hcl 12.5 mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6956(NDC:69618-027) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) Product Characteristics Color white Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code AP;117 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-6956-1 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/02/2017 2 NDC:68788-6956-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 05/02/2017 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6956)