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Loperamide Hydrochloride by Precision Dose Inc.

Medically reviewed on December 4, 2017

Dosage form: suspension
Ingredients: Loperamide Hydrochloride 1mg in 7.5mL
Labeler: Precision Dose Inc.
NDC Code: 68094-107

LOPERAMIDE HYDROCHLORIDE
ORAL SUSPENSION

1 mg/7.5 mL
2 mg/15 mL

Mint Flavor

For Hospital Use Only

Drug Facts

Active Ingredient (in each 7.5 mL)

Loperamide HCl 1 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

Do not use if you have bloody or black stool

Ask a doctor before use if you have
  • 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 right away. (1-800-222-1222)

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • shake well before using
  • use as directed per healthcare professional

Other Information
  • each 30 mL (6 tsp) contains: sodium 13 mg
  • store between 20-25°C (68-77°F)
  • See individual label or shipper label for lot number and expiration date.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Gluten Free

How Supplied

NDC 68094-107-62
7.5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-108-62
15 mL per unit dose cup
Thirty (30) cups per shipper

Manufactured By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
South Beloit, IL 61080

LI911
Rev. 04/13

PRINCIPAL DISPLAY PANEL - 7.5 mL Cup Label

NDC 68094-107-59

PrecisionDose

LOPERAMIDE Hydrochloride
Oral Suspension
1 mg/7.5 mL

Delivers 7.5 mL Shake Well
Gluten free Contains 3 mg Sodium

Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-107(NDC:0113-0645)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (Loperamide) Loperamide Hydrochloride1 mg  in 7.5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
TITANIUM DIOXIDE 
XANTHAN GUM 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68094-107-623 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:68094-107-597.5 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129202/26/2014
Labeler - Precision Dose Inc. (035886746)

 
Precision Dose Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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