FDA Label for Delsym Cough Plus Chest Congestion Dm

Other

Drug Facts

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

Made in England

Otc - Purpose

Delsym Cough+ Chest Congestion Dm

• 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
  
  

Delsym Cough+ Cold Night Time

• 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 you get to sleep
  
  

Liver Warning (Night Time Only)

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Allergy Alert (Night Time Only)

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 (Night Time Only)

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. (Night Time only)
• with any other product containing diphenhydramine, even one used on the skin (Night Time only)
• 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

• liver disease (Night Time only)
• heart disease (Night Time only)
• high blood pressure (Night Time only)
• glaucoma (Night Time only)
• thyroid disease (Night Time only)
• diabetes (Night Time only)
• trouble urinating due to an enlarged prostate gland (Night Time only)
• a breathing problem such as emphysema or chronic bronchitis (Night Time only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

• taking the blood thinning drug warfarin (Night Time only)
• taking sedatives or tranquilizers (Night Time only)

When Using This Product

• do not use more than directed
• excitability may occur, especially in children (Night Time only)
• marked drowsiness may occur (Night Time only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only)
• avoid alcoholic drinks (Night Time only)
• be careful when driving a motor vehicle or operating machinery (Night Time only)

Stop Use And Ask A Doctor If

• nervousness, dizziness, or sleeplessness occur (Night Time only)
• pain, nasal congestion, or cough gets worse or lasts more than 7 days (Night Time only)
• fever gets worse or lasts more than 3 days (Night Time only)
• redness or swelling is present (Night Time only)
• new symptoms occur (Night Time only)
• 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.

Otc - Pregnancy Or Breast Feeding

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

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.

Overdose Warning (Night Time Only)

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see Overdose warning)
• do not take 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
• adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

Other Information

• each 20 mL contains: sodium 13 mg
• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive Ingredients (Delsym Cough+ Chest Congestion Dm)

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

Inactive Ingredients (Delsym Cough+ Cold Night Time)

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 dihydrate, xanthan gum

Questions?

1-866-682-4639

Principal Display Panel - Kit Carton

DAY
NIGHT

NDC 63824-220-22

COMBO
PACK

Delsym^®

COUGH+^®
CHEST
CONGESTION

DM
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

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

Cherry
Flavored Liquid

COUGH+^®COLD

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

• ✓Cough
• ✓Sore Throat
• ✓Fever
• ✓Nasal Congestion
• ✓Body Aches

Mixed Berry
Flavored Liquid

For Ages 12+
TWO–6 fl oz (180 mL) bottles
TOTAL–12 fl oz (360 mL)
For Ages 12+

PRINCIPAL DISPLAY PANEL - Kit Carton - delsym 01