FDA Label for Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time

Other

COUGH+ CHEST CONGESTION DM - AGES 4+

Drug Facts

COUGH+ COLD NIGHT TIME - AGES 6+

Drug Facts

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

Otc - Purpose

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • temporarily reduces fever
    • controls cough to help your child get to sleep
    
    

Otc - Do Not Use

Do not use 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.

Ask A Doctor Before Use If The Child Has

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

Otc - When Using

When using this product do not use more than directed

Stop Use And Ask A Doctor If

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
• 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 fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Keep out of reach of children.

Directions

• do not give more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor

Age (year)	Dose (mL)
children 6 to under 12 years of age	5 mL – 10 mL every 4 hours
children 4 to under 6 years of age	2.5 mL – 5 mL every 4 hours
children under 4 years of age	do not use

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• measure only with the dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; not to exceed 5 doses in any 24-hour period
• children under 6 years of age: do not use

Other Information

• each 5 mL contains: sodium 3 mg
• store between 20-25°C (68-77°F)
• do not refrigerate
• each 10 mL contains: sodium 6 mg
• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihyrate

may contain this ingredient

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

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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
• with any other product containing diphenhydramine, even one used on the skin
• 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.

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 use more than directed (see Overdose warning)
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Principal Display Panel - Kit Carton

NDC 63824-218-22

DAY
NIGHT

COMBO
PACK

Children's
Delsym^®

COUGH+^®
Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

• ✓Relieves Cough
• ✓Relieves Chest
  Congestion
• ✓Thins &
  Loosens
  Mucus

Cherry Flavor

For Ages
4
years+

COUGH+^®Cold

Night Time

Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)

• ✓Relieves Cough
• ✓Relieves
  Stuffy Nose
• ✓Relieves
  Sore Throat
• ✓Reduces Fever

Berry Flavor

For Ages
6
years+

TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)

PRINCIPAL DISPLAY PANEL - Kit Carton - delsym 01