Loperamide Hydrochloride Oral Suspension

leader loperamide by

Drug Labeling and Warnings

leader loperamide by is a Otc medication manufactured, distributed, or labeled by Lohxa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER LOPERAMIDE- loperamide hydrochloride suspension 
Lohxa

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Loperamide Hydrochloride Oral Suspension

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
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • shake well before using
  • only use attached measuring cup to dose product

adults and children 12 years and over

30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

children 9-11 years (60-95 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

children 6-8 years (48-59 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours

children under 6 years (up to 47 lbs)

ask a doctor

Other information

  • each 30 mL (6 tsp) contains: sodium 15 mg
  • store between 20-25 °C (68-77 °F)
  • see side panel 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

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

FOR INSTITUTIONAL USE. 

PRINCIPAL DISPLAY

LEADER LOPERAMIDE 
loperamide hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70166-087(NDC: 49781-089)
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 (UNII: K679OBS311)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
CELLULOSE, MICROCRYSTALLINE (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: 70166-087-1550 in 1 CARTON09/30/2019
115 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129205/30/201403/01/2020
Labeler - Lohxa (079872715)

Revised: 12/2019
Document Id: 9a1ad223-3a7d-3481-e053-2a95a90a9c46
Set id: f0cd847a-5b29-4d6e-bbe7-417bfe6c52a8
Version: 2
Effective Time: 20191219
 
Lohxa