UP AND UP ANTI DIARRHEAL ANTI GAS- loperamide hydrochloride, simethicone tablet

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

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Active ingredient:
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Target Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-diarrheal Anti-gas relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Authorization status:
Abbreviated New Drug Application
Authorization number:
11673-646-89

UP AND UP ANTI DIARRHEAL ANTI GAS- loperamide hydrochloride, simethicone tablet

Target Corporation

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Target Corporation anti-diarrheal/anti-gas Drug Facts

Active ingredients (in each caplet)

Loperamide HCl 2 mg

Simethicone 125 mg

Purpos es

Anti-diarrheal

Anti-gas

Us es

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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

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

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

Stop use and ask a doctor if

if you have bloody or black stool

if you have difficulty swallowing

fever

mucus in the stool

a history of liver disease

a history of abnormal heart rhythm

symptoms get worse

diarrhea lasts for more than 2 days

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

you have difficulty swallowing the caplet

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

adults and children

12 years and over

2 caplets after the first loose stool; 1 caplet after each

subsequent loose stool; but no more than 4 caplets in 24 hours

children 9-11 years

(60-95 lbs)

1 caplet after the first loose stool; ½ caplet after each

subsequent loose stool; but no more than 3 caplets in 24 hours

children 6-8 years

(48-59 lbs)

1 caplet after the first loose stool; ½ caplet after each

subsequent loose stool; but no more than 2 caplets 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

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin,

microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

Ques tions ?

Call 1-888-547-7400

Package/Label Principal Display Panel

Compare to active ingredients in Imodium Multi-Symptom Relief

loperamide hydrochloride and simethicone tablets, 2 mg/125 mg

anti-diarrheal/anti-gas

multi-symptom relief caplet

relieves symptoms of diarrhea plus:

cramps and pressure, bloating, gas

drink plenty of clear fluids to help prevent dehydration caused by diarrhea

take only on an empty stomach (1 hour before or 2 hours after a meal)

take with a full (8 oz.) glass of water

find right dose on chart below. If possible, use weight to dose; otherwise, use age.

each caplet contains: calcium 165 mg, sodium 3 mg

store between 20 -25 C (68 -77 F). Protect from light.

do not use if printed blister unit is broken or torn

ACTUAL SIZE

18 CAPLETS*

18 CAPLETS*

(*CAPSULE-SHAPED TABLETS)

UP AND UP ANTI DIARRHEAL ANTI GAS

loperamide hydrochloride, simethicone tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:116 73-6 46

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

2 mg

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

125 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

2 pieces

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

L0 R1;2;125

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:116 73-6 46 -8 9

18 in 1 CARTON

0 3/14/20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Target Corporation

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 8 37

0 3/14/20 19

Labeler -

T arget Corporation (006961700)

Revised: 6/2019

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