Regular Remedy No. 16

REGULAR REMEDIES NO. 16- alumina, bellis perennis, causticum, collinsonia canadensis, hydrastis canadensis, lac defloratum, natrum muriaticum, nux vomica, plumbum metallicum, sepia liquid
Speer Laboratories, LLC

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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Active Ingredient HPUS: Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia. Equal volumes of each ingredient in: 10X, 30X, LM1 potencies

HPUS indicates that this ingredient is officially part of the Homeopathic Pharmacopia of the United States.

Inactive Ingredients: Citric acid, Potassium sorbate, Purified water.

Uses: Temporarily relieves symptoms of:

Occasional constipation and irregularity
Infrequent urges and peristaltic action

Directions: Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adult Dose: 3 pump sprays. Children 2-12 years: 2 pump sprays.

Keep out of reach of children.

Warnings:

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. If pregnant or breastfeeding, consult a doctor before use.

Other Information: Tamper resistant for your protection. Use only if safety seal is still intact.

Uses: Temporarily relieves symptoms of: occasional constipation and irregularity, infrequent urges and peristaltic action

image description

REGULAR REMEDIES NO. 16
alumina, bellis perennis, causticum, collinsonia canadensis, hydrastis canadensis, lac defloratum, natrum muriaticum, nux vomica, plumbum metallicum, sepia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55926-0016
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933)	ALUMINUM OXIDE	10 [hp_X] in 59 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	10 [hp_X] in 59 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	10 [hp_X] in 59 mL
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR)	COLLINSONIA CANADENSIS ROOT	10 [hp_X] in 59 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	10 [hp_X] in 59 mL
SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A)	SKIM MILK	10 [hp_X] in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	10 [hp_X] in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X] in 59 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	10 [hp_X] in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55926-0016-2	59 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/17/2013

Labeler - Speer Laboratories, LLC (064900125)

Registrant - Speer Laboratories, LLC (064900125)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	api manufacture(55926-0016)