Sunmark anti diarrheal solution

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
  • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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

Ingredients and appearance - Product information

Sunmark anti diarrheal solution- Loperamide hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70677-0054
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loperamide hydrochloride ( UNII: 77TI35393C)( Loperamide - UNII: 6X9OC3H4II ) 1 mgin 7.5 mL

Inactive Ingredients

Ingredient Name Code
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

Color GREEN (opaque, viscous) Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091292 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Package/label principal display panel

COMPARE TO IMODIUM ®A-D ACTIVE INGREDIENT

See New Warning and Directions

Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL

anti-diarrheal

Anti-Diarrheal Oral Solution

CONTROLS THE SYMPTOMS OF DIARRHEA

GLUTEN FREE

MINT FLAVOR

4 FL OZ (120 mL)