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

Regular Remedies No. 16 by

Drug Labeling and Warnings

Regular Remedies No. 16 by is a Homeopathic medication manufactured, distributed, or labeled by Speer Laboratories, LLC, King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 INGREDIENT

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

INDICATIONS & USAGE

Uses: Temporarily relieves symptoms of:

• Occasional constipation and irregularity
• Infrequent urges and peristaltic action

DOSAGE & ADMINISTRATION

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

Keep out of reach of children.

WARNINGS

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 SAFETY INFORMATION

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

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

Labeler - Speer Laboratories, LLC (064900125)

Registrant - Speer Laboratories, LLC (064900125)

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