LOPERAMIDE HYDROCHLORIDE ORAL SUSPENSION

Loperamide Hydrochloride by

Drug Labeling and Warnings

Loperamide Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Precision Dose Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride suspension 
Precision Dose Inc.

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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 - 15 mL Cup Label

NDC: 68094-108-59

PrecisionDose ™

LOPERAMIDE Hydrochloride
Oral Suspension
2 mg/15 mL

Delivers 15 mL Shake Well
Gluten free Contains 7 mg Sodium

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

Principal Display Panel - 15 mL Cup Label
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68094-108(NDC: 0113-0645)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride1 mg  in 7.5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
glycerin (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sucralose (UNII: 96K6UQ3ZD4)  
titanium dioxide (UNII: 15FIX9V2JP)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68094-108-623 in 1 CASE02/26/201409/30/2019
110 in 1 TRAY
1NDC: 68094-108-5915 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129202/26/201409/30/2019
Labeler - Precision Dose Inc. (035886746)

Revised: 6/2019
Document Id: afc39923-15e4-4abe-bb17-5571475605de
Set id: 45b3d2da-5321-4188-a011-281d1ee3cbfa
Version: 2
Effective Time: 20190620
 
Precision Dose Inc.