SEVERE COLD AND FLU RELIEF DAYTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Severe Cold and Flu Relief by

Drug Labeling and Warnings

Severe Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• temporarily relieves common cold and flu symptoms:
  • nasal congestion
  • sinus congestion and pressure 
  • minor aches and pains
  • headache
  • fever 
  • sore throat
  • reduces swelling of nasal passages
  • cough due to minor throat and bronchial irritation
  • temporarily restores freer breathing through the nose
  • promotes nasal and or sinus drainage
  • helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

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

• adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
• child takes more than 4 doses (15 mL each) in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

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

• skin reddening
• blistere
• 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 is 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.
• 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
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
• a sodium restricted diet

Ask a doctor or pharmacist before use if user is

taking the blood thinning drug warfarin

When using this product

do not take more than directed.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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 can cause serious 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 and for children even if you do not notice any signs or symptoms

Directions

• take only as directed (see overdose warning)
• do not take more than 4 doses in 24 hours
• measure only with dosing cup provided. Do not use any other dosing device
• mL = milliliter
• keep dosing cup with product
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

• adults and children12 years and over: 30 mL every 4 hours
• children 6 to under 12 years: 15 mL every 4 hours
• children 4 to under 6 years: ask a doctor
• children under 4 years: do not use

Other information

• each 15 mL contains: sodium 12 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, sodium citrate, sorbitol sucralose, xanthan gum

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredients of VICKS® DAYQUIL® Severe Cold & Flu

Day Time

Severe Cold & Flu Relief 

Acetaminophen 325 mg

 Pain Reliever/Fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mg

Nasal decongestant

• Headache, fever, sore throat, minor aches & pains
• Nasal / sinus congestion & sinus pressure
• Cough
• Chest congestion

For ages 6 years and over

• Max strength
• Alcohol free
• Non-drowsy

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

DOLLAR GENERAL DayTime Severe Cold & Flu Relief

INGREDIENTS AND APPEARANCE

SEVERE COLD AND FLU RELIEF  DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-515
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-515-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/31/2018

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)