MECLIZINE HCL 12.5 MG- meclizine hcl 12.5 mg tablet 
Bryant Ranch Prepack

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.

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Meclizine HCL 12.5

Drug Facts

Active indredient (in each caplet)

Meclizine HCL 12.5 mg

Purpose

Antiemetic

Uses

  • prevents and treats nausea, vomiting, or dizziness due to motion sickness
  • for other uses, consult your doctor

Warnings

Ask a docotor before use if you have

  • glaucoma
  • 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 a doctor before use if you have

  • glaucoma
  • 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 prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranqulizers 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.

Directions

  • adults & children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor

Other information

  • each caplet contains: calcium 51 mg
  • store at room temperature 15º-30ºC (59º-86ºF)
  • This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580

www.reliable1labs.com

HOW SUPPLIED

Product: 71335-0615

NDC: 71335-0615-1 30 TABLET in a BOTTLE

NDC: 71335-0615-2 60 TABLET in a BOTTLE

NDC: 71335-0615-3 90 TABLET in a BOTTLE

NDC: 71335-0615-4 28 TABLET in a BOTTLE

NDC: 71335-0615-5 20 TABLET in a BOTTLE

NDC: 71335-0615-6 120 TABLET in a BOTTLE

NDC: 71335-0615-7 100 TABLET in a BOTTLE

Meclizine Hcl 12.5mg Tablet

Label Image
MECLIZINE HCL 12.5 MG 
meclizine hcl 12.5 mg tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0615(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:71335-0615-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
2 NDC:71335-0615-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
3 NDC:71335-0615-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
4 NDC:71335-0615-4 28 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
5 NDC:71335-0615-5 20 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
6 NDC:71335-0615-6 120 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
7 NDC:71335-0615-7 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2015 06/30/2019
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 11/01/2015 06/30/2019
Labeler - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0615) , RELABEL(71335-0615)

Revised: 9/2019
Bryant Ranch Prepack