DISTRESS DROPS 2121- distress drops liquid 
Professional Complementary Health Formulas

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.

----------

C121

ACTIVE INGREDIENTS

Avena sativa 1X
Asafoetida 3X
Corydalis canadensis 3X
Hyoscyamus niger 3X
Sumbul 6X
Valeriana officinalis 3X
Cicuta virosa 4X
Ignatia amara 4X
Olei gaultheria procumbens 4X
Staphysagria 4X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of feeling distressed or a tendency towards overreaction.*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

In case of overdose, get medical help or contact a poison control center right away.

Keep out of the reach of children.

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

20% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

Distress Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label image

DISTRESS DROPS  2121
distress drops liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-2121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 59 mL
FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN3 [hp_X]  in 59 mL
DICENTRA CANADENSIS ROOT (UNII: Y5JS7YM46F) (DICENTRA CANADENSIS ROOT - UNII:Y5JS7YM46F) DICENTRA CANADENSIS ROOT3 [hp_X]  in 59 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER3 [hp_X]  in 59 mL
FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT6 [hp_X]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 59 mL
CICUTA VIROSA WHOLE (UNII: 3E698BL84C) (CICUTA VIROSA WHOLE - UNII:3E698BL84C) CICUTA VIROSA WHOLE4 [hp_X]  in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED4 [hp_X]  in 59 mL
GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) (GAULTHERIA PROCUMBENS TOP - UNII:830295X963) GAULTHERIA PROCUMBENS TOP4 [hp_X]  in 59 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED4 [hp_X]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63083-2121-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/1984
Labeler - Professional Complementary Health Formulas (167339027)
Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
Establishment
NameAddressID/FEIBusiness Operations
Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-2121)

Revised: 8/2019
Document Id: f2d1919f-44d3-4e0b-aa7a-4a3991c194a2
Set id: 901dfa0f-343b-4385-8b25-7e41a1a7cd1d
Version: 1
Effective Time: 20190815
 
Professional Complementary Health Formulas