Quality Choice 44-375

Quality Choice 44-375

Drug Labeling and Warnings

Drug Details

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ANTI DIARRHEAL- loperamide hcl tablet 
CHAIN DRUG MARKETING ASSOCIATION INC

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Quality Choice 44-375

Active ingredients (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl.

Heart alert: Taking more than directed can cause serious heart problems or death.

Do not use

if you have bloody or black stool.

Ask a doctor before use if you have

  • a fever
  • mucus in the stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

taking antibiotics.

When using this product

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent
loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)
1 caplet after the first loose stool; 1/2 caplet after each subsequent
loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)
1 caplet after the first loose stool; 1/2 caplet after each subsequent
loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)
ask a doctor

Other information

  • store between 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

QC®
Quality
Choice

NDC: 63868-559-12

*Compare to the active ingredient in Imodium® A-D

Anti-Diarrheal
Loperamide HCl Tablets, 2 mg
Anti-Diarrheal

Controls the Symptoms of Diarrhea

Actual Size

12 Caplets

Distributed by C.D.M.A., Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Imodium® A-D.

50844    ORG041737502

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Quality Choice 44-375

Quality Choice 44-375

ANTI DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63868-559
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorGREEN (Light) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63868-559-244 in 1 CARTON05/03/2005
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 63868-559-122 in 1 CARTON05/03/2005
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 63868-559-601 in 1 CARTON05/03/2005
360 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63868-559)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63868-559)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63868-559)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63868-559)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63868-559)

Revised: 3/2019
 
CHAIN DRUG MARKETING ASSOCIATION INC


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