Label: CHILDRENS COLD AND COUGH NIGHTTIME- diphenhydramine hcl, phenylephrine hcl liquid
- NDC Code(s): 55319-079-04
- Packager: Family Dollar (FAMILY WELLNESS)
- 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 November 19, 2019
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- 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
- for the purpose of making your 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
- 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.
- do not give more than 6 doses in 24 hours unless directed by a doctor.
- mL = milliliter
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- shake well before using
Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years do not use
- Other Information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
COMPARE TO ACTIVE INGREDIENTS OF CHILDREN'S TRIAMINIC® NIGHTTIME COLD & COUGH*
Cold & Cough Nighttime
Diphenhydramine HCL Antihistamine/Cough Suppressant
Phenylephrine HCL Nasal Decongestant
For Ages 6 to 11 Years
- Runny, Stuffy Nose
- Itchy Throat
FL OZ (mL)
Dosing Cup Included
*This product is not manufactured or distributed by GSK, Consumer Healthcare, distributor of Children's Triaminic® NightTime Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
- Package Label
INGREDIENTS AND APPEARANCE
CHILDRENS COLD AND COUGH NIGHTTIME
diphenhydramine hcl, phenylephrine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-079 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) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-079-04 1 in 1 BOX 11/30/2014 1 118 mL in 1 BOTTLE, PLASTIC; 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 11/30/2014 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)