TONSIN- allium cepa, pulsatilla pratensis, sambucus nigra, ferrum phosphoricum, hepar sulphuris, kali muriaticum, natrum muriaticum, kali bichromicum, mercurius solubis tablet 
PRIVATE LABEL BRANDS CC

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 INGREDIENTS (OTC- ACTIVE INGREDIENT SECTION)

Allium cepa D3 HPUS

Pulsatilla Pratensis D3 HPUS

Sambucus nigra D3 HPUS

Ferrum Phosphoricum D6 HPUS

Hepar Sulphuris D6 HPUS

Kali Muriaticum D6 HPUS

Natrum Muriaticum D6 HPUS

Kali Bichromicum D6 HPUS

Mercurius Solubis D10 HPUS

PURPOSE (DOSAGE & ADMINISTRATION SECTION)

Temporarily relieves sneezing and watery nasal discharge

Temporarily relieves colds with loss of taste and smell

Temporarily relieves colds and easing mucus production reducing swelling in nasal passages

Temporarily relieves colds, runny nose, inflammation of sinus passages and throat

Temporarily relieves runny then stuffy nose with thick slimy mucus

Temporarily relieves sinusitus, earache, and sore throat

Temporarily relieves sneezing, tickling in throat loss of taste and smell

Temporarily relieves thick green/ yellow nasal discharge and glue ear

Temporarily relieves colds, ear, eye infections and sore throat

USES (OTC- PURPOSE SECTION)

Temporarily relieves symptoms associated with sinusitis, hay fever and colds. Such as: sneezing, runny nose, mucus, and minor sore throat.

KEEP OUT OF REACH OF CHILDREN (OTC- KEEP OUT OF REACH OF CHILDREN SECTION)

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS (INDICATIONS & USAGE SECTION)

Adults and children aged 12 years or older:

Dissolve 2 tablets in mouth 3x daily. May be taken hourly in acute cases

Children between 2 and 12 years old:

Dissolve 1 tablet in mouth 3x daily. May be taken hourly in acute cases.

Infants: 1 crushed tablet diluted in cooled, boiled, water.

OTHER INFORMATION (INSTRUCTIONS FOR USE SECTION)

Store below 77°F and away from direct sunlight.

WARNING (WARNINGS SECTION)

These tablets contain lactose and should be used with caution by individuals with a severe sensitivity or intolerance to lactose as well as diabetics.

STOP USE AND ASK DOCTOR IF (OTC- STOP USE SECTION)

if symptoms persist for more than 3 days or worsen or if sore throat persists for more that 2 days or occurs with a fever, headache, rash, nausea or vomiting.

ASK A DOCTOR (OTC- ASK DOCTOR SECTION)

ASK A DOCTOR BEFORE USING IN CHILDREN UNDER 3 YEARS OF AGE

IF PREGNANT OR BREASTFEEDING, (OTC- PREGNANCY OR BREAST FEEDING SECTION)

ask a health professional before use.

INACTIVE INGREDIENTS (INACTIVE INGREDIENT SECTION)

Lactose monohydrate, crosscarmelose, magnesium stearate.

Principle Display Panel- 150 tablet container

Tonsin Tablets Carton

TONSIN 
allium cepa, pulsatilla pratensis, sambucus nigra, ferrum phosphoricum, hepar sulphuris, kali muriaticum, natrum muriaticum, kali bichromicum, mercurius solubis tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70773-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 100 [hp_X]
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM6 [hp_X]  in 100 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 100 [hp_X]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]  in 100 [hp_X]
ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456) ALLIUM CEPA WHOLE3 [hp_X]  in 100 [hp_X]
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS3 [hp_X]  in 100 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 100 [hp_X]
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE6 [hp_X]  in 100 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS10 [hp_X]  in 100 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE (UNII: 029TFK992N)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70773-100-151 in 1 CARTON12/25/2017
11 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/25/2017
Labeler - PRIVATE LABEL BRANDS CC (539043103)
Registrant - PRIVATE LABEL BRANDS CC (539043103)
Establishment
NameAddressID/FEIBusiness Operations
Herbal and Homeopathic (Pty) Ltd.638215520manufacture(70773-100)

Revised: 12/2017
Document Id: 6157d00e-9894-6038-e053-2a91aa0ab6e6
Set id: 6157d00e-9893-6038-e053-2a91aa0ab6e6
Version: 1
Effective Time: 20171227
 
PRIVATE LABEL BRANDS CC