Meclizine HCL 12.5 mg by Bryant Ranch Prepack Meclizine HCL 12.5

Meclizine HCL 12.5 mg by

Drug Labeling and Warnings

Meclizine HCL 12.5 mg by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

NDC: 71335-0615-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-0615-2: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-0615-3: 90 Tablets in a BOTTLE, PLASTIC

NDC: 71335-0615-4: 28 Tablets in a BOTTLE, PLASTIC

NDC: 71335-0615-5: 20 Tablets in a BOTTLE, PLASTIC

NDC: 71335-0615-6: 120 Tablets in a BOTTLE, PLASTIC

NDC: 71335-0615-7: 100 Tablets in a BOTTLE, PLASTIC

Meclizine Hcl 12.5mg Tablet

Label
MECLIZINE HCL 12.5 MG 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71335-0615(NDC: 69618-027)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code AP;117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71335-0615-130 in 1 BOTTLE; Type 0: Not a Combination Product11/23/202002/28/2022
2NDC: 71335-0615-260 in 1 BOTTLE; Type 0: Not a Combination Product03/31/202102/28/2022
3NDC: 71335-0615-390 in 1 BOTTLE; Type 0: Not a Combination Product03/31/202102/28/2022
4NDC: 71335-0615-428 in 1 BOTTLE; Type 0: Not a Combination Product03/31/202102/28/2022
5NDC: 71335-0615-520 in 1 BOTTLE; Type 0: Not a Combination Product03/31/202102/28/2022
6NDC: 71335-0615-6120 in 1 BOTTLE; Type 0: Not a Combination Product03/31/202102/28/2022
7NDC: 71335-0615-7100 in 1 BOTTLE; Type 0: Not a Combination Product03/31/202102/28/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart33611/01/201502/28/2022
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0615) , RELABEL(71335-0615)

Revised: 4/2024
 

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