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Loperamide Hydrochloride by Precision Dose Inc.

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.

← See all Loperamide Hydrochloride brands

Medically reviewed on Dec 3, 2018

Further information

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

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