Severe Cold and Cough by Family Dollar (FAMILY WELLNESS) Drug Facts

Severe Cold and Cough by

Drug Labeling and Warnings

Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid 
Family Dollar (FAMILY WELLNESS)

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Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

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

Warnings

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 every day while using this product

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

  • skin reddening
  • blisters
  • rash

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

  • 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
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking

  • the blood thinning drug warfarin
  • sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough or nasal congestion 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 signs 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 (180 mL) 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
  • adults and children 12 years and over
    • 30 mL every 4 hours
  • children under 12 years of age; do not use 

Other information

  • each 30 mL contains: potassium 10 mg
  • each 30 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS OF THERA® EXPRESSMAX® NIGHTTIME SEVERE COLD AND COUGH*

Severe Cold & Cough

NIGHTTIME

Acetaminophen (Pain Reliever/Fever Reducer)

Diphenhydramine HCl (Cough Suppressant/Antihistamine)

Phenylephrine HCl (Nasal Decongestant)

For Relief of:

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

Alcohol Content: 10%

MAXIMUM STRENGTH

PER 4 HOUR DOSE

BERRY FLAVOR

FL OZ (mL)

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

*This product is not manufactured or distributed by GSK Consumer Health, distributor Theraflu® ExpressMax® Nighttime Severe Cold & Cough.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY, CHESAPEAKE,VA 23320

Product Label

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

FAMILY WELLNESS Severe Cold & Cough Berry Flavor

SEVERE COLD AND COUGH  NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-602
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-602-83245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/202007/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/30/202007/31/2025
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 3/2024