Assured Day time Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Assured Day time Cold and Cough

Bio-Pharm, Inc.

ASSURED ® Day Time Cold & Cough


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients (in each TSP (5 mL)) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCL 2.5 mg Nasal decongestant

Assured Day time Cold and Cough Uses

Temporarily relieves:

  • nasal & sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with cold

Warnings

Do not use

  • in a child under 4 years of age
  • in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor
Age Dose
Children under 4 years of age Do not use
Children 4 to under 6 years of age 1 TSP (5 mL)
Children 6 to under 12 years of age 2 TSP (10 mL)

Other Information

  • each TSP contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: Do no use if foil seal over mouth of the bottle is torn, broken or missing.

Inactive Ingredients

benzoic acid, citric acid anhydrous, EDTA disodium dihydrate, FD&C red #40, flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 59741-201-06

ASSURED ®

Day Time
Cold & Cough*

Cough Suppressant:
Dextromethorphan HBr

Nasal Decongestant:
Phenylephrine HCl

Relief for:

• Cough• Stuffy Nose

Cherry
Flavor

4 FL OZ (118 mL)

Assured Day time Cold and Cough

Assured Day time Cold and Cough

Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59741-201
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
saccharin sodium
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
BENZOIC ACID
water
EDETIC ACID
SODIUM CITRATE
sorbitol
propylene glycol
Prunus Serotina Bark

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59741-201-06 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-11-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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