RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable 
Apotheca Inc.

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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Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg


Purpose

Antiemetic


Uses

Warnings


Do not use in children under 12 years of age unless directed by a doctor


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 it you are taking sedatives or tranquilizers.


When using this product

  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution 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 the poison control center immediately.


Directions

Dosage should be taken one hour before travel starts

Adults and children 12 years of age and older:

Chew 1-2 tablets once daily, or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor


Other information


Inactive ingredients

aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.


Questions or comments?

1-800-645-2158


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

label

RUGBY TRAVEL SICKNESS  MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-246(NDC:0536-1018)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
SUCROSE (UNII: C151H8M554)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Product Characteristics
ColorpinkScore2 pieces
ShapeROUND (Biconvex Uncoated Tablet with Bisect) Size8mm
FlavorImprint Code 21G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12634-246-0010 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:12634-246-01100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:12634-246-7130 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:12634-246-7925 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:12634-246-8020 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:12634-246-8515 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:12634-246-911 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:12634-246-966 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/19/2014
Labeler - Apotheca Inc. (051457844)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Inc.051457844relabel(12634-246) , repack(12634-246)

Revised: 12/2015
Document Id: 280dc4d4-7774-3c13-e054-00144ff8d46c
Set id: 280dc4d4-7773-3c13-e054-00144ff8d46c
Version: 1
Effective Time: 20151229
 
Apotheca Inc.