KIDS COUGH AND FEVER RELIEF- atropa belladonna and drosera rotundifolia and prunus laurocerasus leaf and rumex crispus root and

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ), PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757), RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C), POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF), VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)
Available from:
Similasan Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
fever nighttime spasmodic, hacking, tickling cough fever, hacking, dry cough hoarse throat, nasal congestion, dry cough worse with cold air nasal congestion, dry/tickling cough hoarse throat, spasmodic cough at night Temporarily relieves symptoms of dry/tickling cough, fever, and nasal congestion due to throat and bronchial irritation occurring with a cold.
Authorization status:
unapproved homeopathic
Authorization number:
59262-259-25

KIDS COUGH AND FEVER RELIEF- atropa belladonna and drosera rotundifolia and prunus

laurocerasus leaf and rumex crispus root and polygala senega root and verbascum

thapsus syrup

Similasan Corporation

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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Kids Cough and Fever Relief

Active Ingredient

Belladonna* 6X

* containing 0.0000000016% alkaloids conculated as hyoscyamine

Purpose

fever

Active Ingredient

Drosera 3X

Purpose

nighttime spasmodic, hacking, tickling cough

Active Ingredient

Laurocerasus 4X

Purpose

fever, hacking, dry cough

Active Ingredient

Rumex crispus 4X

Purpose

hoarse throat, nasal congestion, dry cough worse with cold air

Active Ingredient

Senega officinalis 6X

Purpose

nasal congestion, dry/tickling cough

Active Ingredient

Verbascum thapsus 6X

Purpose

hoarse throat, spasmodic cough at night

Uses:

Temporarily relieves symptoms of dry/tickling cough, fever, and nasal congestion due to throat and

bronchial irritation occurring with a cold.

Warnings

Initial exacerbation of symptoms may occur.

Do not exceed recommended dosage.

Not intended for children under 2.

A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if:

if symptoms worsen or persist for more than 72 hours

Directions:

For children age 2 and over:

AGE DOSE

FREQUENCY

2-12

2.5 ml

3 to 6 times daily

(every 4 hours)

5 ml

3 to 6 times daily

(every 4 hours)

Replace cap tightly after every use

Or use as directed by a licensed health care professional.

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Purified water, Sorbitol, Sodium chloride, Potassium sorbate, Citric acid

Questions?

Reach our representatives at 1-800-240-9780

or getinfo@similasanusa.com

www.Similas anUSA.com

Principal Display Panel

NDC 59262-259-25

Similas an

Kids Cough & Fever Relief

Cough & Fever Syrup

118 ml / 4fl oz

KIDS COUGH AND FEVER RELIEF

atropa belladonna and drosera rotundifolia and prunus laurocerasus leaf and rumex crispus root and polygala

senega root and verbascum thapsus syrup

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 26 2-259

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

ATROPA BELLADONNA

6 [hp_X]

Similasan Corporation

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

in 118 mL

DRO SERA RO TUNDIFO LIA (UNII: QR44N9 XPJQ) (DROSERA ROTUNDIFOLIA -

UNII:QR44N9 XPJQ)

DROSERA

ROTUNDIFOLIA

3 [hp_X]

in 118 mL

PRUNUS LAURO CERASUS LEAF (UNII: F26 P2D4757) (PRUNUS LAUROCERASUS

LEAF - UNII:F26 P2D4757)

PRUNUS

LAUROCERASUS LEAF

4 [hp_X]

in 118 mL

RUMEX CRISPUS RO O T (UNII: 9 N1RM2S6 2C) (RUMEX CRISPUS ROOT -

UNII:9 N1RM2S6 2C)

RUMEX CRISPUS ROOT

4 [hp_X]

in 118 mL

PO LYGALA SENEGA RO O T (UNII: M7T6 H7D4IF) (POLYGALA SENEGA ROOT -

UNII:M7T6 H7D4IF)

POLYGALA SENEGA

ROOT

6 [hp_X]

in 118 mL

VERBASCUM THAPSUS (UNII: C9 TD27U172) (VERBASCUM THAPSUS -

UNII:C9 TD27U172)

VERBASCUM THAPSUS

6 [hp_X]

in 118 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 26 2-259 -

118 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED HOMEOPATHIC

0 7/0 2/20 13

Labeler -

Similasan Corporation (111566530)

Revised: 7/2013

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