CAREONE DIARRHEA CONTROL- loperamide hcl suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)
Available from:
American Sales Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-diarrheal controls symptoms of diarrhea, including Travelers’ Diarrhea
Authorization status:
Abbreviated New Drug Application
Authorization number:
41520-767-26, 41520-767-34

CAREONE DIARRHEA CONTROL- loperamide hcl suspension

American Sales Company

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American Sales Company Diarrhea Control Drug Facts

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 mg

Purpos e

Anti-diarrheal

Us e

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

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

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

fever

mucus in the stool

a history of liver disease

a history of abnormal heart rhythm

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

symptoms get worse

diarrhea lasts for more than 2 days

you get abdominal swelling or bulging. These may be signs of a serious condition.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

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

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

Compare to the active ingredient in Imodium® A-D

DIARRHEA CONTROL

Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL/Anti Diarrheal

Controls the symptoms of diarrhea

Mint Flavor

Anti-Diarrheal Oral Solution

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

each 30 mL contains: sodium 15 mg

store between 20-25°C (68-77°F)

See New Warning and Directions

8 FL OZ (240mL)

CAREONE DIARRHEA CONTROL

loperamide hcl suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41520 -76 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LO PERAMIDE HYDRO CHLO RIDE (UNII: 77TI3539 3C) (LOPERAMIDE -

UNII:6 X9 O C3H4II)

LOPERAMIDE

HYDROCHLORIDE

1 mg

in 7.5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GLYCERIN (UNII: PDC6 A3C0 OX)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

XANTHAN GUM (UNII: TTV12P4NEE)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

GREEN (o paque, visco us)

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41520 -76 7-26

120 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /20 /20 16

2

NDC:41520 -76 7-34

240 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /20 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 129 2

0 9 /20 /20 16

American Sales Company

Labeler -

American Sales Company (809183973)

Revised: 2/2020

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