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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
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time (NDC 63824-218). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, ask a doctor before use if the child has, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
| Active ingredients (in each 10 mL) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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.
When using this product do not use more than directed
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.
| 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 |
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
, xanthan gumanhydrous 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
, xanthan gumThis product contains acetaminophen. Severe liver damage may occur if your child takes:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
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.
1-866-682-4639
You may also report side effects to this phone number.
NDC 63824-218-22
DAY
NIGHT
COMBO
PACK
Children's
Delsym®
COUGH+®
Chest Congestion
DM
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Cherry Flavor
For Ages
4
years+
COUGH+®Cold
Night Time
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Berry Flavor
For Ages
6
years+
TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)
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