Label: MECLIZINE- meclizine hcl 12.5 mg tablet
- 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.
Updated April 25, 2019
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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.
- dosage 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 (866) 562-2756 (M - F, 8AM - 4PM EST).Close
- HOW SUPPLIED
NDC: 50090-3017-3 30 TABLET in a BOTTLE
NDC: 50090-3017-7 28 TABLET in a BOTTLE
NDC: 50090-3017-8 90 TABLET in a BOTTLEClose
- Meclizine HCl 12.5 mg
- INGREDIENTS AND APPEARANCE
meclizine hcl 12.5 mg tablet
Product 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)