HEADACHE RELIEF- atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root tablet

Headache Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

Headache Relief

Drug Facts

Active ingredients

• Active ingredients:

  Purpose

• Belladonna 12X HPUS (0.0000000000003% Alkaloids, calculated):

  headache

• Gelsemium Sempervirens 6X HPUS:

  headache

• Ipecacuanha 6X HPUS:

  headache

• Iris Versicolor 6X HPUS:

  headache

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

Pharmacopoeia of the United States.

Uses

■ Temporarily relieves headaches

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:

■ symptoms persist for more than 7 days or worsen.

■ new symptoms occur.

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.

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: 54973-4008-1

SINCE 1903

Hyland's

Headache

Relief *

TOUGH ON PAIN - GENTLE ON YOU

NO ACETAMINOPHEN

NO IBUPROFEN

NO KNOWN DRUG

INTERACTIONS

100 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF 
atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR 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: 54973-4008-1	1 in 1 CARTON	04/03/2020
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		04/03/2020

Labeler - Hyland's (028570695)

Registrant - Standard Homeopathic Company (Hyland's) (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-4008) , pack(54973-4008) , label(54973-4008)