Prescription Drug Information: Nitrofurantoin (Page 3 of 3)

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 Capsules, USP (monohydrate/macrocrystals) 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 Capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body.

NDC 68788-8258-0 bottle of 10

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.]

Rx Only

CLINICAL STUDIES:

Controlled clinical trials comparing Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) 100 mg p.o. q12h and nitrofurantoin (macrocrystals) capsule 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.

Mfg. By: Swiss Pharmaceutical Co. Inc.
Tainan City, 74442 Taiwan


Mfg. for: Trigen Laboratories, LLC
Alpharetta, GA 30005

1-770-509-4500

www.trigenlab.com

Distributor Logo

PLR-NITRO-00002 Rev.: 11/2021

Repackaged By: Preferred Pharmaceuticals Inc.

Package/Label Display Panel

Nitrofurantoin Monohydrate Macrocrystals Capsules 100mg
(click image for full-size original)
NITROFURANTOIN
nitrofurantoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8258(NDC:13811-719)
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
Product Characteristics
Color yellow (opaque yellowish brown) , yellow (pale yellow) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8258-0 10 CAPSULE in 1 BOTTLE None
2 NDC:68788-8258-1 14 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208516 09/16/2022
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-8258)

Revised: 09/2022 Preferred Pharmaceuticals Inc.

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