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Name:Nasotuss
Manufacturer:Hawthorn Pharmaceuticals, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Nasotuss Liquid

NASOTUSS  - chlorcyclizine hydrochloride, codeine phosphate and phenylephrine hydrochloride liquid 
Hawthorn Pharmaceuticals, Inc.

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.

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Nasotuss Liquid

Active ingredients

(in each 5 mL teaspoonful)
Chlorcyclizine Hydrochloride 25 mg
Codeine Phosphate 10 mg
Phenylephrine Hydrochloride 10 mg

Purpose

Antihistamine, Antitussive, Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of the nasal passages

Warnings

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 before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

Do not exceed recommended dosage.
Adults and children
12 years of age
and older:

1 teaspoonful (5 mL) every
6 to 8 hours, not to exceed
3 teaspoonfuls in a
24 hour period.
Children 6 to under
12 years of age:



1/2 teaspoonful
(2.5 mL) every
6 - 8 hours, not to exceed 1 1/2
teaspoonfuls in a
24 hour period.
Children under 6
years of age:
Consult a doctor


Other information

Store at 20° to 25° C (68° to 77°F).

Inactive ingredients

Citric Acid, Sodium Citrate Dihydrate, Sucralose, Propylene Glycol, Sorbitol, Glycerin, Raspberry Flavor, and Deionized Water.

Questions? Comments?

Call 1-888-455-5253 Monday - Friday, 8:00 a.m.- 5:00 p.m. (CT)
Serious side effects associated with use of this product may be reported to this number.

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Patent Pending

Manufactured for:
Hawthorn Pharmaceuticals, Inc.
Madison, MS  39110

HI262  08/10

Product Packaging

The packing below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL label:

NDC 63717-276-16

Patent Pending

nasotuss Liquid

Antihistamine / Antitussive / Decongestant

Each teaspoonful (5mL) for oral administration contains:

Chlorcyclizine HCl................................25 mg
Codeine Phosphate..............................10 mg
Phenylephrine HCl................................10 mg

Rx Only

For Professional Use

Dye Free / Sugar Free / Alcohol Free

Raspberry Flavor

HAWTHORN
PHARMACEUTICALS, INC.

16 fl oz (473 mL)

USUAL DOSAGE:  See Drug Facts for Complete Dosage Recommendations.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to the consumer.

Dispense in a tight, light-resistant container with a child-resistant closure.

Call you doctor for medical advise about side effects.  You may report side effects
to FDA at 1-800-FDA-1088 (Toll Free).

Manufactured for:
Hawthorn Pharmaceuticals, Inc., Madison, MS  39910

HL219  08/10

Nasotuss Liquid Packaging


Nasotuss Liquid Packaging







NASOTUSS 
chlorcyclizine hydrochloride, codeine phosphate, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63717-276
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride 25 mg  in 5 mL
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Trisodium Citrate Dihydrate  
Sucralose  
Propylene Glycol  
Sorbitol  
Glycerin  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63717-276-16 473 mL in 1 BOTTLE None
2 NDC:63717-276-99 12 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 15 mL in 1 BOTTLE This package is contained within the CARTON (63717-276-99)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/08/2010

Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 12/2010 Hawthorn Pharmaceuticals, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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