Indications and uses
temporarily relieves sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritations as may occur with a cold
Nighttime Cold and Cough
- Manufacturer
- CVS Pharmacy
- Effective date
- 2023-01-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:39:55
Label at a glance#
ProductNighttime Cold and Cough childrens
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided Do not use any other dosing device keep dosing cup with product mL= milliliter shake well before using Age Dose children 6 to under 12 years of age 10 mL every 4 hours children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 5 mL)
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Purposes
Antihistamine/Cough suppressant
Nasal decongestant
Uses
- temporarily relieves
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritations as may occur with a cold
Warnings
Do not use
- in a child under 4 years of age
- 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.
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as chronic bronchitis
Ask a doctor or pharmacist before use if the child is
taking sedatives or tranquilizers
When using this product,
- do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache.
These could be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Do not give more than 6 doses in 24 hours unless directed by a doctor.
- measure only with dosing cup provided Do not use any other dosing device
- keep dosing cup with product
- mL= milliliter
- shake well before using
| Age | Dose |
| children 6 to under 12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | do not use unless directed by a doctor |
| children under 4 years | do not use |
Other Information
- each 5 mL contains: sodium 3 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
- protect from light
Inactive ingredients
acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Children's
Nighttime Cold & Cough
DIPHENHYDRAMINE HCI Antihistamine; Cough suppressant
PHENYLEPHRINE HCl Nasal decongestant
Relieves:
- Cough
- Runny, stuffy nose
- Itchy throat
Alcohol free
For Ages 6 to 11 Years
Grape Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
Package Label
Products#
Every source-derived product name is available through these pages.
- Nighttime Cold and Cough childrens
- Diphenhydramine HCl, Phenylephrine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- SODIUM BENZOATE
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- MALTITOL
- PROPYLENE GLYCOL
- WATER
- FD&C RED NO. 40
- TRISODIUM CITRATE DIHYDRATE
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-379 | 69842-379-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| MALTITOL | D65DG142WK | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e4eb66f0-7647-420d-9da5-6bca356a8d65 | 17cda1c4-0916-4e30-afdd-43d4ef7d1333 | 2023-01-19 | Warnings | e4eb66f0-7647-420d-9da5-6bca356a8d65 17cda1c4-0916-4e30-afdd-43d4ef7d1333 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.