Night Time Severe Cold and Cough

Manufacturer
Fred's, Inc. | Aurohealth LLC
Effective date
2020-11-27
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:57

Label at a glance#

ProductNight Time Severe Cold and Cough
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor TBSP = Tablespoon, mL = milliliter Age Dose adults and children 12 years of age and over 30 mL (2 TBSP) children under 12 years of age do not use Attention: use only enclosed ...

Storage and handling

each 30 mL contains: potassium 9 mg, sodium 15 mg Store at 20-25 o C (68-77 o F) TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 30 mL (2 TBSP))

Acetaminophen, USP 650 mg
Diphenhydramine HCl, USP 25 mg
Phenylephrine HCl, USP 10 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer
Antihistamine/Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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

OTC - DO NOT USE SECTION

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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 product 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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • 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

OTC - STOP USE SECTION

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

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • measure the dose correctly using the enclosed dosing cup
  • take every 4 hours in dosing cup provided, while symptoms persist
  • do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor
  • TBSP = Tablespoon, mL = milliliter

Age
Dose
adults and children 12 years of age and over
30 mL (2 TBSP)
children under 12 years of age
do not use

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: potassium 9 mg, sodium 15 mg
  • Store at 20-25oC (68-77oF)
  • TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue no.1, FD&C Red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

1-855-274-4122

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Nighttime Severe Cold & Cough.

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

DISTRIBUTED BY:
Fred's, Inc.
4300 NEW GETWELL RD
MEMPHIS, TN38118
www.fredsinc.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

freds
Pharmacy


NDC 55315-004-33

Nighttime
SEVERE COLD
& COUGH
Maximum Strength Per 4 Hour Dose

Each dose (per 30 mL) of Syrup contains:
650 mg - ACETAMINOPHEN, USP
(Pain Reliever/Fever Reducer)
25 mg - DIPHENHYDRAMINE HCl, USP
(Cough Suppressant/Antihistamine)
10 mg - PHENYLEPHRINE HCl, USP
(Nasal Decongestant)


  • Nasal Congestion
  • Headache
  • Sore Throat Pain
  • Runny Nose
  • Body Ache
  • Cough
  • Fever

8.3 FL OZ (245.5 mL)

Berry Flavor
Alcohol Content: 10%

Compare to the Active Ingredients In
Theraflu® ExpressMaxTM
Nighttime Severe Cold&Cough*



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 8.3 FL OZ (245.5 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 8.3 FL OZ (245.5 mL Bottle)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-00455315-004-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6cf6d7a6-d38d-44fe-9841-932c7d6c8438d773c939-b959-4dff-8a82-b085f2acb32c2020-11-27WarningsExact identifier
spl id: 6cf6d7a6-d38d-44fe-9841-932c7d6c8438
spl set id: d773c939-b959-4dff-8a82-b085f2acb32c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.