Otc - Active Ingredient
ACTIVE INGREDIENTS:
Sanguinaria canadensis 6X
Hydrastis canadensis 6X
Silicea 6X
Kali muriaticum 3X
Pulsatilla 3X
Alpha Sh Tablet
FDA Label NDC 53499-1391
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Alpha Sh (NDC 53499-1391). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
INACTIVE INGREDIENT:
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Otc - Purpose
PURPOSE:
Temporarily relieves these symptoms: helps decongest sinus openings and passages, shrinks swollen nasal membranes and promotes sinus drainage.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Indications & Usage
INDICATIONS AND USAGE:
Temporarily relieves these symptoms: helps decongest sinus openings and sinus passages, shrinks swollen nasal membranse, promotes sinus drainage.
Warnings
WARNINGS:
Do not use this product for headache pain for more than 10 days (for adults) or 5 days (for children).
If symptoms persist, get worse, or are accompanied by a high fever, or if new symptoms occur, consult a doctor.
These can be signs of a serious condition.
Dosage & Administration
DOSAGE:
Directions:
Sublingual medication. Place tablets under tongue at least 15 minutes before or half hour after eating, brushing teeth, or drinking anything except water.
Adults and children 12 years of age and older:
take 2 tablets every two hours until relieved.
Children 2 to 12:
take 1 every two hours until relieved
Children under 2:
Consult a doctor.
Otc - Pregnancy Or Breast Feeding
Pregnancy or Breast Feeding:
If pregnant or breast feeding, ask a healthcare professional before use.
Overdosage
Overdosage:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Otc - Ask Doctor
Ask the Doctor:
Do not take this product for headache pain for more than 10 days (for adults) or 5 days (for children).
Stop use and ask a doctor if symptoms persist, get worse, or are accompanied by a high fever, or if new symptoms occur.
These could be signs of a serious condition.
Package Label.Principal Display Panelboericke And Tafel Alpha Sh 21801390 40 Tablets
Alpha SH_21801390_04
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