GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE- 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:
ATLANTIC BIOLOGICALS CORP.
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:
17856-0111-2, 17856-0111-3, 17856-0111-4, 17856-0111-5, 17856-0111-6

GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE- loperamide

hcl suspension

ATLANTIC BIOLOGICALS CORP.

----------

Amerisource Bergen Loperamide Hydrochloride Oral Suspension 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

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 antibiotics

When using this product

Stop use and ask a doctor if

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.

fever

mucus in the stool

a history of liver disease

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.

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 (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 1/2 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 1/2 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

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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI,FL 33179

1-800-719-9260

Package/Label Principal Display Panel

Compare to Imodium® A-D active ingredient

Loperamide Hydrochloride Oral Suspension

anti-diarrheal

Controls the Symptoms of Diarrhea

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

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

mint flavor

NDC 17856-0111-06

GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE

loperamide hcl suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:178 56 -0 111(NDC:46 122-111)

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 (UNII: K6 79 OBS311)

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

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

GLYCERIN (UNII: PDC6 A3C0 OX)

CELLULO SE, MICRO CRYSTALLINE (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)

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:178 56 -0 111-

72 in 1 BOX, UNIT-DOSE

0 2/26 /20 19

1

10 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:178 56 -0 111-

72 in 1 BOX, UNIT-DOSE

0 2/26 /20 19

2

5 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:178 56 -0 111-

72 in 1 BOX, UNIT-DOSE

0 3/14/20 19

3

15 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

4

NDC:178 56 -0 111-

72 in 1 BOX, UNIT-DOSE

0 3/14/20 19

4

7.5 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

5

NDC:178 56 -0 111-

50 in 1 BOX, UNIT-DOSE

0 4/16 /20 19

5

15 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

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 2/26 /20 19

ATLANTIC BIOLOGICALS CORP.

Labeler -

AT LANT IC BIOLOGICALS CORP. (047437707)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ATLANTIC BIOLOGICALS CORP.

0 4743770 7

repack(178 56 -0 111) , relabel(178 56 -0 111)

Revised: 4/2019

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