Loperamide Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Loperamide Hydrochloride

Precision Dose Inc.

LOPERAMIDE HYDROCHLORIDE ORAL SUSPENSION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Loperamide Hydrochloride

Loperamide Hydrochloride

Loperamide Hydrochloride SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68094-108(NDC:0113-0645)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 1 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-108-59 15 in 1 CUP, UNIT-DOSE
2 10 in 1 TRAY
3 NDC:68094-108-62 3 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091292 2014-02-26


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Be sure to consult your doctor before taking any medication!
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