fulton street market cold description, usages, side effects, indications, overdosage, supplying and lots more!

fulton street market cold

Access Business Group LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Access Business Group LLC Multi-Symptom Cold Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • cough
  • stuffy nose
  • sneezing and runny nose
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the child has

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

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 right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4-6 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 lbs

under 4 years

do not use
36-47 lbs 4-5 years do not use unless directed by a doctor
48-95 lbs 6-11 years 2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each teaspoon contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

children's

grape flavor

pain relief plus

multi-symptom cold

cough suppressant

nasal decongestant

antihistamine

fever reducer

pain reliever

oral suspension

contains 4 ingredients:

fever & sore throat - acetaminophen

cough - dextromethorphan HBr

stuffy nose - phenylephrine HCl

sneezing & runny nose - chlorpheniramine maleate

Principal Display Panel
Multi-Symptom Cold Carton Image 1 Multi-Symptom Cold Carton Image 2

fulton street market cold

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10056-903
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
CARRAGEENAN
D&C RED NO. 33
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
polysorbate 80
water
SODIUM BENZOATE
sorbitol
SUCROSE
XANTHAN GUM
ANHYDROUS CITRIC ACID
CALCIUM SULFATE
TRIBASIC SODIUM PHOSPHATE

Product Characteristics

Color
PURPLE (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:10056-903-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-08-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.