Cough and Cold Nighttime: Package Insert and Label Information

COUGH AND COLD NIGHTTIME- acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
Walgreens

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.

Active ingredient (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 my of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine even one used on the skin
  • 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product,

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcoholic, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating a machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • new symptoms occur
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • adults and children 12 years and older: 20 mL every 4 hours while symptoms last
  • children under 12 years of age: do not use

Other information

  • each 20 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, sorbitol, xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Maximum Strength Delsym® Adult Night Time Cough & Cold active ingredients††

NIGHTTIME

Cough & Cold

ACETAMINOPHEN 650 mg / PAIN RELIEVER, FEVER REDUCER

DIPHENHYDRAMINE HCI 25 mg / ANTIHISTAMINE, COUGH SUPPRESSANT

PHENYLEPHRINE HCI 10 mg / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves headaches, fever & sore throat
  • Controls cough
  • Relieves nasal congestion
  • ages 12 years & older

FL OZ (mL)

MIXED BERRY FLAVOR

†† This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Delsym® Adult Night Time Cough & Cold

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com ©2018 Walgreen Co.

Package Label

Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg
(click image for full-size original)

WALGREENS NightTime Cough & Cold

COUGH AND COLD NIGHTTIME
acetaminophen diphenhydramine hci phenylephrine hci liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0747
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
WATER
EDETATE DISODIUM
GLYCERIN
PROPYL GALLATE
PROPYLENE GLYCOL
SODIUM BENZOATE
SUCRALOSE
XANTHAN GUM
FD&C RED NO. 40
FD&C BLUE NO. 1
SORBITOL
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color Score
Shape Size
Flavor BERRY (MIXED) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0747-06 177 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/31/2018
Labeler — Walgreens (008965063)

Revised: 10/2019 Walgreens

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