Major Pharmaceuticals Loperamide Hydrochloride Oral Solution Drug Facts

Major Pharmaceuticals Loperamide Hydrochloride Oral Solution Drug Facts

Drug Labeling and Warnings

Drug Details

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LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution 
Major Pharmaceuticals

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Major Pharmaceuticals Loperamide Hydrochloride Oral Solution 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

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

  • 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
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • shake well before using
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • mL = milliliter

adults and children

12 years and over

30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours

children 9-11 years

(60-95 lbs)

15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours

children 6-8 years

(48-59 lbs)

15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours

children 2-5 years

(34 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Other information

  • each 30 mL contains: sodium 15 mg
  • store between 20-25°C (68-77°F)

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

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

See New Warning and Directions

Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL

Anti-Diarrheal Oral Solution

Controls the Symptoms of Diarrhea

Anti-Diarrheal Oral Solution

Mint Flavor

COMPARE TO the active ingredient of IMODIUM® A-D

4 FL OZ (120 mL)

645-5c-loperamide-hydrochloride-oral-solution.jpg
LOPERAMIDE HYDROCHLORIDE 
loperamide hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0904-6836
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREEN (opaque, viscous) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-6836-20120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129211/29/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2019
 
Major Pharmaceuticals


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