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CVS Childrens Nighttime Multi Symptom Cold drug information

ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE
CVS PHARMACY · ORAL

Product NDC: 51316-733

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE
Labeler / manufacturerCVS PHARMACY
RouteORAL
Drug classDrug class not supplied in source label
Product NDC51316-733
Label effective date2026-08-19

Official product label reference

CVS Childrens Nighttime Multi Symptom Cold — CVS PHARMACY

This page contains 16 source sections for ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE, oral route. Label set 9b244ac8-4ca7-43a0-b328-88f15f0fcc9d, version 6.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses ▪ 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

Purpose

Active ingredients (in each 10 mL) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant Table text from source: | Active ingredients (in each 10 mL) | Purposes | | Acetaminophen 325 mg | Pain reliever/fever reducer | Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant | Phenylephrine HCl 5 mg | Nasal decongestant
Dosage and administration — label text
Directions ▪ this product does not contain directions or complete warnings for adult use ▪ do not give more than directed (see Overdose warning) ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ children 6 years to 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in 24-hours period ▪ children under 6 years of age: do not use
Warnings
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: ▪ 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 child sleepy ▪ with any other drug 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ 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) 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 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 fever, rash, or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. 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 for adults as well as for children, even if you do not notice any signs or symptoms.
Unclassified section
Drug Facts
Active ingredient
Active ingredients (in each 10 mL) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant Table text from source: | Active ingredients (in each 10 mL) | Purposes | | Acetaminophen 325 mg | Pain reliever/fever reducer | Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant | Phenylephrine HCl 5 mg | Nasal decongestant
Do not use
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 child sleepy ▪ with any other drug 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use
Ask a doctor before use if the child have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ 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)
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the child is ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers
While using this medicine
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
When to stop use and seek help
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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Child safety
Keep out of reach of children. 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 for adults as well as for children, even if you do not notice any signs or symptoms.
Overdose information
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 for adults as well as for children, even if you do not notice any signs or symptoms.
Storage and handling
Other information ▪ each 10 mL contains: sodium 4 mg ▪ store at room temperature ▪ do not refrigerate
Inactive ingredient
Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions
Questions or comments? 1-866-467-2748

Official sources and product identifiers

Substances listed: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

RxNorm identifiers: 1375932

Package NDC codes

51316-733-04

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.