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DONATUSSIN  - chlophedianol hydrochloride, guaifenesin and phenylephrine hydrochloride syrup 
Laser Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredients
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Guaifenesin 120 mg
Phenylephrine Hydrochloride 5 mg

Purpose

Antitussive
Expectorant
Nasal Decongestant
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages
Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist ibalgin before taking this product.

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed 4 doses in a 24 hour period.

Adults and
children 12
years of age
and over:
2 teaspoonfuls (10 mL)
every 6 to 8 hours, not to
exceed 8 teaspoonfuls in
24 hours
Children 6 to
under 12 years
of age:
1 teaspoonful (5 mL)
every 6 to 8 hours, not to
exceed 4 teaspoonfuls in
24 hours
Children 2 to
under 6 years
of age:
1/2 teaspoonful (2.5 mL)
every 6 to 8 hours, not to
exceed 2 teaspoonfuls in
24 hours
Children under
2 years of age:
Consult a doctor

Store at 59°-86°F (15°-30°C)

Berry Vanilla Flavor, Bitter Mask, Citric Acid, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

Call 1-864-286-8229
LASER
Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

The packaging below represents the labeling currently used.
Principal display panel and side panel for 473 mL label:
NDC:  16477-185-01

Donatussin
SYRUP

New Improved
Formula

Antitussive

Expectorant

Nasal Decongestant
Each 5 mL (1 teaspoonful) contains:
Chlophedianol HCl...........................12.5 mg
Guaifenesin.....................................120 mg
Phenylephrine HCl...............................5 mg

Patent Pending
Berry Vanilla Flavor
LASER

16 fl oz (473 mL)
For full prescribing information, see the product foldout.
Store at 59°-86°F (15°-30°C)
Tamper-evident by foil seal under cap.  Do not use if foil
seal is brokenor missing.
THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.
Dispense in a tight, light-resistant container as defined in the
USP/NF with a child-resistant closure.
The labeling for this product includes professional labeling which
is not intended for use by the general public.
WARNING:  KEEP THIS AND ALL DRUGS OUT OF REACH OF
CHILDREN.  IN CASE OF OVERDOSE, GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY.

LASER
Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC  29615
Patent Pending
Rev. 08/2011

Donatussin SYRUP Packaging

Donatussin SYRUP Packaging


DONATUSSIN 
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-185
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride 12.5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 120 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Sucralose  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY (Berry Vanilla) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16477-185-01 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/28/2011

Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture

Revised: 09/2011 Laser Pharmaceuticals, LLC


Source: https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=64325


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