HEADACHE AND MIGRAINE REAL RELIEF - cyclamen purpurascens tuber, antimony trisulfide, aluminum oxide, lycopodium clavatum spore, silver nitrate, digitalis, melilotus officinalis top and nitroglycerin tablet, chewable 
HOMEOLAB USA INC

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 HPUS

Cyclamen europaeum (Sowbread) 4X
Antimonium crudum (Antimonous sulfide) 9X
Alumina (Alumina) 9X
Lycopodium clavatum (Clubmoss) 5X
Argentum nitricum (Silver nitrate) 9X
Digitalis purpurea (Foxglove) 9X
Melilotus officinalis (Yellow sweet clover) 4X
Glonoium (Glonoin) 6X

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

USES

This homeopathic medicine helps relieve symptoms associated with headaches and migraines:

- throbbing pain

- dizziness

- vertigo

- nausea

PURPOSE

vertigo, dizziness, one-sided headache
pain in forhead, nausea
dizziness, vertigo, nausea
throbbing pain and pain in temples
headache from mental exhaustion
head feels heavy
vertigo, throbbing frontal headache
snow-headache, sun-headache

WARNINGS


Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

DIRECTIONS

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional.


Age
 Dose
Adults and children 12 years of age and older2 tablets
Children 6 to 11 years of age1 tablet
Children under 6 years of ageAsk a doctor

OTHER INFORMATION

Store at room temperature (68 - 77F).

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

Lactose, magnesium stearate.


CARTON

image of carton label


HEADACHE AND MIGRAINE  REAL RELIEF
cyclamen europaeum, antimonium crudum, alumina, lycopodium clavatum, alumina, lycopodium clavatum, argentum nitricum, digitalis purpurea, melilotus officinalis, glonoinum tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLAMEN PURPURASCENS TUBER (CYCLAMEN PURPURASCENS TUBER) CYCLAMEN PURPURASCENS TUBER4 [hp_X]
ANTIMONY TRISULFIDE (ANTIMONY CATION (3+)) ANTIMONY CATION (3+)9 [hp_X]
ALUMINUM OXIDE (ALUMINUM OXIDE) ALUMINUM OXIDE9 [hp_X]
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE5 [hp_X]
SILVER NITRATE (SILVER CATION) SILVER CATION9 [hp_X]
DIGITALIS (DIGITALIS) DIGITALIS9 [hp_X]
MELILOTUS OFFICINALIS TOP (MELILOTUS OFFICINALIS TOP) MELILOTUS OFFICINALIS TOP4 [hp_X]
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScore no score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:60512-6016-090 TABLET, CHEWABLE in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/25/2012

Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIOperations
HOMEOLAB USA INC202032533manufacture

Revised: 07/2012 HOMEOLAB USA INC