DAYTIME RELIEF SEVERE COLD AND FLU- acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin solution

Daytime Relief Severe Cold and Flu by

Drug Labeling and Warnings

Daytime Relief Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Fred's, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

PURPOSE

Active ingredients (in each 15 mL tablespoon)                           Purpose

Acetaminophen USP 325 mg .............................................. Pain reliever/fever reducer
Dextromethorphan HBr USP 10 mg ............................................... Cough suppressant
Guaifenesin USP 200 mg .......................................................................... Expectorant
Phenylephrine HCl USP 5 mg ........................................................ Nasal decongestant

Uses

  

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

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

• adult takes more than 4 doses (30 mL each) in 24 hours
• 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
• 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.
• 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 enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• 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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed – see Overdose warning
•  use dose cup or tablespoon (TBSP)
•  do not exceed 4 doses (60 mL) (4 TBSP) per 24 hours
•  mL = milliliter; TBSP = tablespoon

• adults & children 12 years & over: 30 mL (2 TBSP) every 4 hours
• children 6 to under 12 years: 15 mL (1 TBSP) every 4 hours
• children 4 to under 6 years: ask a doctor
• children under 4 years: do not use

• when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

• each 15 mL tablespoon contains: sodium 49 mg
• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous citric acid, flavor, FD&C yellow No. 6, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or Comments?

1-855-274-4122

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

fred's Pharmacy

NDC: 55315-359-31

MAXIMUM STRENGTH

DAYTIME RELIEF
SEVERE
Cold & Flu

Each dose (per 15 mL) (1 TBSP) of oral solution contains:
325 mg - Acetaminophen USP (Pain reliever/Fever reducer)
5 mg – Phenylephrine HCl USP (Nasal decongestant)
10 mg - Dextromethorphan HBr USP (Cough suppressant)
200 mg - Guaifenesin USP (Expectorant)

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Cough
• Chest Congestion

Non-Drowsy Alcohol Free
12 FL OZ (354 mL)

Compare To Vicks® Dayquil® SEVERE COLD & FLU RELIEF*

INGREDIENTS AND APPEARANCE

DAYTIME RELIEF SEVERE COLD AND FLU 
acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-359
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
RASPBERRY (UNII: 4N14V5R27W)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	ORANGE (Orange to Reddish Orange)	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-359-31	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/26/2015

Labeler - Fred's, Inc. (005866116)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(55315-359)