MIGRAINE RELIEF- gelsemium sempervirens root, strychnos nux-vomica seed, iris versicolor root, sanguinaria canadensis root, atropa belladonna and nitroglycerin tablet

Migraine Relief by

Drug Labeling and Warnings

Migraine Relief by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc, Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Migraine Relief

Drug Facts

Active ingredients

• Active ingredients:

  Purpose

• Belladonna 6X HPUS (0.0000003% Alkaloids, calculated):

  pounding pain, light and noise sensitivity

• Gelsemium 6X HPUS:

  dull headache

• Glonoinum 12X HPUS:

  throbbing headache, dizziness

• Iris Versicolor 6X HPUS:

  headache, blurred vision, nausea

• Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated):

  frontal headache, dizziness

• Sanguinaria Canadensis 6X HPUS:

  headache

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Uses

■ Temporarily relieves symptoms of adult migraine headaches including:

■ throbbing headache  ■ pounding pain ■ dull headache

■ frontal headache  ■ light sensitivity ■ noise sensitivity

■ dizziness  ■ nausea  ■ blurred vision

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Do not use more than directed.

Consult a physician if you have: ■ never had migraines diagnosed by a medical professional. ■ a headache that is different from your usual migraines. ■ the worst headache of your life. ■ fever and stiff neck. ■ headaches beginning after or caused

by head injury, exertion, coughing or bending. ■ experienced your first headache after the age of 50. ■ daily headaches. ■ a migraine so severe as to require bed rest. ■ been vomiting with your migraine headache.

Keep this and all medications out of the reach of children.

In case of emergency or accidental overdose, contact a medical professional or

Poison Control Center immediately. Hyland’s may also be contacted for emergency

information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

• Adults and children 12 years and over:

  Dissolve 2 tablets under tongue every 15 minutes

  up to 4 doses, then every 4 hours until relieved.

• Children under 12 years:

  Consult a physician.

Other information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident

bottle cap band is broken or missing.

Drug Facts (continued)

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT

ACCEPTED MEDICAL EVIDENCE.

NOT FDA EVALUATED.

Principal Display Panel

HOMEOPATHIC

NDC: 54973-4030-1

SINCE 1903

Hyland's

Migraine

Relief*

TOUGH ON PAIN - GENTLE ON YOU

NO ACETAMINOPHEN

NO IBUPROFEN

NO CAFFEINE

NO KNOWN DRUG

INTERACTIONS

100 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

MIGRAINE RELIEF 
gelsemium sempervirens root, strychnos nux-vomica seed, iris versicolor root, sanguinaria canadensis root, atropa belladonna and nitroglycerin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4030
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	6 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	12 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (White to Off White)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4030-1	1 in 1 CARTON	03/30/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/30/2020

Labeler - Hyland's Inc (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-4030) , pack(54973-4030) , label(54973-4030)