Clindamycin palmitate hydrochloride labels and packages

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Clindamycin palmitate hydrochloride
CLINDAMYCIN PALMITATE HYDROCHLORIDE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

Mfd. by: Lyne Laboratories, Inc. Brockton, MA 02301

R4-08/12

NDC 0374-5070-01

Clindamycin Palmitate Hydrochloride for Oral Solution, USP (Pediatric)

75 mg*/5 mL when reconstituted

100 mL (when mixed) Rx only

Date of reconstitution ________________________

Warning - NOT FOR INJECTION Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate reconstituted solution.

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

DOSAGE AND USE: See accompanying prescribing information.

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 HCl equivalent to 75 mg clindamycin.

Mfd. by: Lyne Laboratories, Inc. Brockton, MA 02301

R4-08/12


References

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e1cb8caa-1e49-41e7-bbd8-a2e75bea2fe4