PRINCIPAL DISPLAY PANEL — DICYCLOMINE HCL TABLETS, USP BOTTLE LABEL

4 CONTRAINDICATIONS

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)], nursing mothers [see Use in Specific Populations (8.3)], and in patients with:

unstable cardiovascular status in acute hemorrhage
myasthenia gravis [see Warnings and Precautions (5.4)]
glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)]
obstructive uropathy [see Warnings and Precautions (5.8)]
obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)]
severe ulcerative colitis [see Warnings and Precautions (5.7)]
reflux esophagitis

16 HOW SUPPLIED/STORAGE AND HANDLING

Dicyclomine Hydrochloride Capsules USP, 10 mg

10 mg blue capsules with a white powder fill, imprinted logo LANNETT on the cap and 0586 on the body, supplied in bottles of 100, 500, and 1000 capsules. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP.

Bottles of 100 capsules: NDC 0527-0586-01
Bottles of 500 capsules: NDC 0527-0586-05
Bottles of 1000 capsules: NDC 0527-0586-10

Dicyclomine Hydrochloride Tablets USP, 20 mg

20 mg blue, round, flat-faced, beveled edge tablets, debossed LAN over 1282, supplied in bottles of 100, 500 and 1000 tablets. To prevent fading, avoid exposure to direct sunlight. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP.

Bottles of 100 tablets: NDC 0527-1282-01
Bottles of 500 tablets: NDC 0527-1282-05
Bottles of 1000 tablets: NDC 0527-1282-10