Label: CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE- diphenhydramine hcl, phenylephrine hcl liquid
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- NDC Code(s): 49580-0379-4
- Packager: P & L Development, LLC
- 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.
Drug Label Information
Updated April 5, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
- Uses
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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 the 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
- a breathing problem such as chronic bronchitis
- chronic cough that lasts, or as occurs with asthma
- cough that occurs with too much phlegm (mucus)
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
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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 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use - Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough
children's triacting nighttime
Cold & Cough
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
antihistamine/
cough suppressant
nasal decongestant
relieves:
- cough
- runny, stuffy nose
- itchy throat
for ages 6 to 11
Grape Flavor
FL OZ (mL)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Package Label
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INGREDIENTS AND APPEARANCE
CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE
diphenhydramine hcl, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0379 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 6.25 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) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MALTITOL (UNII: D65DG142WK) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0379-4 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 - P & L Development, LLC (101896231)
