CELL SALTS- calc. fluor., calc. phos., calc.sulph., ferrum phosphoricum, kali mur., kali phos., kali sulph., mag. phos., nat. mur., nat. phos., nat.sulphuricum, silicea liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Cell 4831L

INDICATIONS & USAGE SECTION

A formulation of the 12 tissue salts for symptoms associated with digestion, exhaustion, inflammation and sensitive skin.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, take 3 drops) one to four times daily or as directed by a health professional.

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

QUESTIONS SECTION

newtonlabs.net - Questions? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

INACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

A formulation of the 12 tissue salts for symptoms associated with digestion, exhaustion, inflammation and sensitive skin.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Calc. fluor. 15x, Calc. phos. 15x, Calc.sulph. 15x, Ferrum phos. 15x, Kali mur. 15x, Kali phos. 15x, Kali sulph. 15x, Mag. phos. 15x, Nat. mur. 15x, Nat. phos. 15x, Nat.sulphuricum 15x, Silicea 15x.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

CELL SALTS
calc. fluor., calc. phos., calc.sulph., ferrum phosphoricum, kali mur., kali phos., kali sulph., mag. phos., nat. mur., nat. phos., nat.sulphuricum, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4831
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	15 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	15 [hp_X] in 1 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	15 [hp_X] in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	15 [hp_X] in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	15 [hp_X] in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	15 [hp_X] in 1 mL
POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG)	POTASSIUM SULFATE	15 [hp_X] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	15 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	15 [hp_X] in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	15 [hp_X] in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	15 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4831-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4831)