Label: BRONCHIAL AND BREATHING AIDE- aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet
- NDC Code(s): 68466-4098-1
- Packager: Schwabe Mexico S.A. de C.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Updated November 11, 2019
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Directions: Sublingual medication.
Place tablets under tongue at least 15 minutes before or 30 minutes after eating, brushing teeth, or drinking anything except water.
Adults and children 12 years of age and older: 2 tablets every two hours until relieved.
Children under 12 years of age: Consult a doctor.
- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Ask a doctor before use if you have :
a persisient or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emplysema or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptons occur, symptoms worsen or do not get better within 7 days for adults or 5 days for children, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with a rash or persistent headache.
These could be signs of a serious condition.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BRONCHIAL AND BREATHING AIDE
aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-4098 Route of Administration SUBLINGUAL, SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X] Tin (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) Tin 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white (B;T) Score no score Shape ROUND (BT) Size 8mm Flavor Imprint Code B;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68466-4098-1 1 in 1 BOX 04/01/2017 1 100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2017 Labeler - Schwabe Mexico S.A. de C.V (812805901) Establishment Name Address ID/FEI Business Operations Schwabe Mexico S.A. de C.V. 812805901 manufacture(68466-4098)