Active Ingredients For Nighttime (In Each 10 Ml)
Acetaminophen 325 mg
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Multi Symptom Cold And Multi Symptom Nighttime Cold (NDC 69842-820). 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 active ingredients for nighttime (in each 10 ml), active ingredients for daytime (in each 5 ml), purpose for nighttime, purpose for daytime, uses, warnings, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Pain reliever / fever reducer
Antihistamine / Cough suppressant
Nasal Decongestant
Cough suppressant
Expectorant
Nasal decongestant
Nighttime
Daytime
NIGHTTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Nighttime
Daytime
Nighttime
Daytime
Nighttime
Nighttime
Daytime
Nighttime
Daytime
Nighttime
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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Nighttime
Daytime
| Age | Dose |
| children 6 years to under 12 years | 10 mL every 4 hours |
| children 4 years to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
Nighttime
Daytime
Nighttime
citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Daytime
citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**
Children's
multi-symptom
Nighttime Cold
ACETAMINOPHEN 325 mg (pain reliever / fever reducer)
DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)
PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)
Relieves:
Nasal and chest congestion
Reduces fever
Soothes cough and sore throat
Berry Flavor Liquid
Dosage Cup Included
Ages 6 - 11 Years
FL OZ (mL)
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold
DAYTIME
Compare to active ingredients in Children's Mucinex® Multi-Symptom Cold*
Children's
multi-symptom cold
DEXTROMETHORPHAN HBr 5 mg (Cough Suppressant)
GUAIFENESIN 100 mg (expectorant)
PHENYLEPHRINE HCI 2.5 mg (Nasal Decongestant)
Relieves:
Nasal and chest congestion
Soothes cough
Thins and loosens mucus
Berry Flavor Liquid
Dosage cup included
Ages 4 to 11 years
FL OZ (mL)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
1-800-SHOP CVS
* Please review the disclaimer below.