CALC PHOS- calcium phosphate tablet

CALC PHOS by

Drug Labeling and Warnings

CALC PHOS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIRECTIONS

Adults & Children ages 6 - 12:

4 tablets.

Children ages 2 - 6:

2 tablets. Dissolve under tongue

3 times a day. Use more frequently

(every 15 minutes for up to 8 doses)

with acute conditions.

INDICATIONS

Temporarily relieves symptoms of gum or tooth sensitivity.

FORMULA

Calcarea Phosphorica 6X HPUS

in a base of Acacia Gum, Lactose N.F.

SPL UNCLASSIFIED SECTION

"HPUS" indicates that the active

ingredients are in the official

Homeopathic Pharmacopœia of the

United States.

WARNINGS

As with any drug, ask a doctor before use if pregnant or breast feeding.

Do not use more than directed.

Consult a physician if

• symptoms persist for more than 72 hours or worsen.
• swelling increases, rash or fever develops.
• irritation,pain or rednes persists or worsens.

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

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland's may be contacted for emergency information about our products 24 hours, a day 7 days per week at (800) 624-9659.

QUESTIONS?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

HOMEOPATHIC

NDC: 54973-2043-01

Hyland's®

#2

Calc Phos 6X

Gum & Tooth

Sensitivity*

500 TABLETS

INGREDIENTS AND APPEARANCE

CALC PHOS 
calcium phosphate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-2043
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-2043-1	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2013
2	NDC: 54973-2043-2	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2013
3	NDC: 54973-2043-3	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/1940

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-2043)