Vibramycin Monohydrate (Page 4 of 5)

HOW SUPPLIED

Product Name Dosage Form Product Description NDC Number and Pack Size
Vibramycin Hyclate (doxycycline hyclate) Capsules Light blue capsule imprinted with “VIBRA” on one half and “PFIZER 095” on the other half. NDC 0069-0950-50100 mg doxycycline bottles of 50
Vibra-Tabs (doxycycline hyclate) Tablets Salmon colored film-coated tablets, imprinted on one side with “VIBRA-TABS” and “PFIZER 099” on the other side. NDC 0069-0990-50100 mg doxycycline bottles of 50PRODUCT DISCONTINUED
Vibramycin Calcium (doxycycline calcium) Syrup-oral suspension Raspberry-apple flavored oral suspension. NDC 0069-0971-9350 mg/5mL: 1 pint (473 mL) bottle orNDC 0069-0971-74NDC 0069-0971-9550 mg/5mL: 1 pint (473 mL) bottle (with carton)
Vibramycin Monohydrate (doxycycline monohydrate) Oral suspension Raspberry-flavored, dry powder for oral suspension. NDC 0069-0970-6525 mg/5mL, 2 oz (60 mL) bottles

All products are to be stored below 86°F (30°C) and dispensed in tight, light-resistant containers (USP).

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCES

  1. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
  2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
  3. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
  4. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Logo

LAB-0074-23.0
Revised: 4/2021

PRINCIPAL DISPLAY PANEL — 25 mg Oral Suspension Bottle Label

NDC 0069-0970-65

60 mL when reconstituted

Vibramycin®
(doxycycline monohydrate)

FOR ORAL SUSPENSION

25 mg/5 mL*

RASPBERRY FLAVORED

Pfizer
Pfizer LabsDivision of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 25 mg Oral Suspension Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/5 mL Bottle Carton

NDC 0069-0970-65

60 mL when reconstituted

Vibramycin®
(doxycycline monohydrate)

FOR ORAL SUSPENSION

25 mg/5 mL*

RASPBERRY FLAVORED

Pfizer
Pfizer LabsDivision of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 25 mg/5 mL Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC 0069-0971-95

Pfizer

Vibramycin®
calcium

(doxycycline calcium)
syrup

50 mg/5 mL*

ORAL SUSPENSION FOR ORAL USE ONLY

RASPBERRY/APPLE FLAVORED

SHAKE WELL BEFORE USING

1 Pint (473 mL)

Rx only

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Carton

Pfizer

NDC 0069-0971-95

Vibramycin ®
calcium
(doxycycline calcium)
syrup

50 mg/5 mL*

ORAL SUSPENSION
FOR ORAL USE ONLY

IMPORTANT
THIS CLOSURE IS NOT CHILD-RESISTANT.

RASPBERRY/APPLE FLAVORED

SHAKE WELL BEFORE USING

1 Pint (473 mL)

Rx only

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label — NDC 0069-0971-74

NDC 0069-0971-74

Pfizer

Vibramycin®
calcium

(doxycycline calcium)
syrup

50 mg/5 mL*

ORAL SUSPENSION
FOR ORAL USE ONLY

RASPBERRY/APPLE FLAVORED

SHAKE WELL BEFORE USING

1 Pint (473 mL)Rx only

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label -- NDC 0069-0971-74
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Carton — NDC 0069-0971-74

Pfizer

NDC 0069-0971-74

Vibramycin®
calcium

(doxycycline calcium)
syrup

50 mg/5 mL*

ORAL SUSPENSION
FOR ORAL USE ONLY

IMPORTANT
THIS CLOSURE IS NOT
CHILD-RESISTANT.

RASPBERRY/APPLE FLAVORED

SHAKE WELL BEFORE USING

1 Pint (473 mL)Rx only

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Carton -- NDC 0069-0971-74
(click image for full-size original)

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