Indications and uses
• temporarily relieves: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes due to hay fever • nasal and sinus congestion • cough due to minor throat and bronchial irritation as may occur with a cold
Childrens Night Time Cold and Cough
- Manufacturer
- L. Perrigo Company
- Effective date
- 2022-08-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:55:52
Label at a glance#
ProductChildrens Night Time Cold and Cough
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
• may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. • use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device. Age Dose children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 10 mL
Storage and handling
• each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F)
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
- itchy nose or throat
- runny nose
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation 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
- to make a 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
- may cause marked drowsiness
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or occur with fever
- cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.
Age | Dose |
children under 4 years of age | do not use |
children 4 to under 6 years of age | do not use unless directed by a doctor |
children 6 to under 12 years of age | 10 mL |
Other information
- each 5 mL contains: sodium 3 mg
- store at 20-25°C (68-77°F)
Inactive ingredients
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions or comments?
1-800-719-9260
Principal Display Panel
GoodSense®
Ages 6 to 12 Years
Children’s
Night Time
Triacting
Cold & Cough
Antihistamine/Cough Suppressant (Diphenhydramine HCl)
Nasal Decongestant (Phenylephrine HCl)
● Cough Relief
● Runny, Stuffy Nose
● Itchy Throat
Grape Flavor
Compare to active ingredients of Children’s Triaminic® Night Time Cold & Cough
4 FL OZ (118 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0113-0808-26 | 2024-01-30 | C162847 | 48780-1 | 1030e365-68a4-111a-e063-dadaa90a10e2 | Perrigo Children’s Night Time Cold & Cough Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Childrens Night Time Cold and Cough
- Diphenhydramine HCl, Phenylephrine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0113-0808 | 0113-0808-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| c7e2bb1a-345e-4c53-a010-b9d62ab998a6 | 6f51e788-012d-41d6-94cd-b752c4e01325 | 2024-07-11 | Warnings | 6f51e788-012d-41d6-94cd-b752c4e01325 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.