Clindamycin Palmitate Hydrochloride (Page 5 of 5)

REFERENCES

1.
Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.
2.
CLSI. Performance Standards for Antimicrobial Susceptibility Testing: 26th ed — CLSI supplement M 100S. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
3.
CLSI. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Tenth Edition. CLSI document M07-A10. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
4.
CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – Eighth Edition. CLSI document M11-A8. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
5.
CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

The brands listed are trademarks of their respective owners.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 12/2016
CLINOS:R3

PRINCIPAL DISPLAY PANEL – 75 mg/5 mL

NDC 0378-8730-35 Rx only

Clindamycin
Palmitate
Hydrochloride
for Oral Solution, USP
(Pediatric)

75 mg*/5 mL
when reconstituted

One Bottle 100 mL (when mixed)

Reconstitute with 75 mL of water. Add
a large portion of the water and shake
vigorously; add the remainder of the
water and shake until the solution is
uniform.

*When reconstituted with water as
directed, each 5 mL (teaspoonful) of
solution contains clindamycin palmitate
hydrochloride, USP equivalent to
75 mg of clindamycin.

Do not refrigerate reconstituted
solution.

Keep container tightly closed. Shake
well before each use. Discard any
unused portion 2 weeks after
reconstitution.

Date of reconstitution________________

Warning – NOT FOR INJECTION

Usual Dosage: See accompanying
prescribing information.

Keep this and all medications out of
the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

M8730:35:1C:R1

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Mylan.com

Clindamycin Palmitate Hydrochloride for Oral Solution, USP (Pediatric) 75 mg/5 mL Carton Label
(click image for full-size original)
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin granule, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8730
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PALMITATE HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 75 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ICODEXTRIN
DIMETHICONE
ETHYLPARABEN
POLOXAMER 188
SILICON DIOXIDE
SUCROSE
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8730-35 100 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203063 05/26/2016 11/30/2018
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 12/2016 Mylan Pharmaceuticals Inc.

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