Label: COLD AND CONGESTION CHILDRENS NIGHTTIME- diphenhydramine hci, phenylephrine hcl liquid
- NDC Code(s): 0363-0058-04
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
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 11, 2020
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- Active ingredients (in each 10 mL)
Do not use
- to sedate a child or to make a child sleepy
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- with any other product containing diphenhydramine, even one used on skin.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlem (mucus)
- a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena.
Ask a doctor or pharmacist before use if you are
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with a fever
- cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache.
These could be signs of a serious condition.
- do not take more than 6 doses in any 24-hour period
- do not exceed recommended dosage
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
COLD & CONGESTION
DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients††
- Alcohol Free
- 6 years & older
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY : WALGREEN CO
200 WILMOT RD., DEERFIELD, IL 60015
- Package Label
INGREDIENTS AND APPEARANCE
COLD AND CONGESTION CHILDRENS NIGHTTIME
diphenhydramine hci, phenylephrine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength 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) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) MALTITOL (UNII: D65DG142WK) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0058-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/31/2016 Labeler - Walgreens (008965063)