Nitrofurantoin Mono (Page 4 of 4)

OVERDOSAGE

Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.

DOSAGE AND ADMINISTRATION

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

HOW SUPPLIED

Nitrofurantoin monohydrate/macrocrystals capsules are available as 100 mg opaque black and yellow capsules imprinted “(band) Macrobid (band)” on one half and “52427-285” on the other.

NDC 54348-849-06 bottle of 06

NDC 54348-849-10 bottle of 10

NDC 54348-849-14 bottle of 14

Store at controlled room temperature (59° to 86°F or 15° to 30°C).

Rx Only

CLINICAL STUDIES

Controlled clinical trials comparing nitrofurantoin monohydrate/macrocrystals capsules 100 mg p.o. q12h and nitrofurantoin macrocrystals 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic eradication of susceptible pathogens in each treatment group.

Distributed by: Alvogen, Inc.
Pine Brook, NJ 07058 USA

Rev: 08/2018 PI303-08

Package Labeling: (54348-849-06)

Label32
(click image for full-size original)

Package Labeling: (54348-849-10)

Label33
(click image for full-size original)

Package Labeling: (54348-849-14)

Label34
(click image for full-size original)

NITROFURANTOIN MONO
nitrofurantoin monohydrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54348-849(NDC:47781-303)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 25 mg
NITROFURANTOIN MONOHYDRATE (NITROFURANTOIN) NITROFURANTOIN 75 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
SUCROSE
Product Characteristics
Color yellow, black Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code Macrobid;52427285
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54348-849-06 1 BOTTLE in 1 BOX contains a BOTTLE
1 6 CAPSULE in 1 BOTTLE This package is contained within the BOX (54348-849-06)
2 NDC:54348-849-10 1 BOTTLE in 1 BOX contains a BOTTLE
2 10 CAPSULE in 1 BOTTLE This package is contained within the BOX (54348-849-10)
3 NDC:54348-849-14 1 BOTTLE in 1 BOX contains a BOTTLE
3 14 CAPSULE in 1 BOTTLE This package is contained within the BOX (54348-849-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020064 07/10/2019
Labeler — PharmPak, Inc. (175493840)

Revised: 08/2019 PharmPak, Inc.

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