Label: CHILDRENS NIGHT TIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl solution
- NDC Code(s): 0113-0808-26
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated August 2, 2022
If you are a consumer or patient please visit this version.
- Active ingredients (in each 5 mL)
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
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts or as occurs with asthma
- a breathing problem such as chronic bronchitis
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.
- 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.
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
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Ages 6 to 12 Years
Cold & Cough
Antihistamine/Cough Suppressant (Diphenhydramine HCl)
Nasal Decongestant (Phenylephrine HCl)
● Cough Relief
● Runny, Stuffy Nose
● Itchy Throat
Compare to active ingredients of Children’s Triaminic® Night Time Cold & Cough
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
CHILDRENS NIGHT TIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0808 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0808-26 1 in 1 CARTON 01/12/2022 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/12/2022 Labeler - L. Perrigo Company (006013346)