Label: MECLIZINE- meclizine hcl 12.5 mg tablet
- NDC Code(s): 66424-386-01, 66424-386-10
- Packager: SDA Laboratories, Inc.
- 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 February 1, 2018
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- Active ingredient (in each caplet)
Meclizine HCl 12.5mgClose
prevents and treats nausea, vomiting or dizziness associated with motion sicknessClose
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
- 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.
When using this product
- do not exceed recommended dosage
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- doage should be taken 1 hour before travel starts
Adults and children 12 years and over
take 2 or 4 caplets once daily or as directed by doctor
- Other information
- Tamper Evident: do not use if safety seal under cap is broken or missing
- store at room temperature 20°-25°C (68°-77°F)
- Inactive ingredients
Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acidClose
Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).Close
- PRINCIPAL DISPLAY PANEL
Meclizine HCl 12.5mg
• Motion Sickness • Nausea • Vomiting
- INGREDIENTS AND APPEARANCE
meclizine hcl 12.5 mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-386 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) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (WHITE COLOR) 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:66424-386-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 2 NDC:66424-386-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 02/01/2018 Labeler - SDA Laboratories, Inc. (948067889) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(66424-386) , pack(66424-386) , analysis(66424-386)