DAYTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled 
Freds Inc

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Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains 
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation

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

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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough as occurs with smoking, asthma, 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.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness or sleeplessness occur
  • 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 the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat

Inactive ingredients

butylated hydroxyanisole*, butylated hydroxytoluene* carminic acid*, edible white ink, D&C yellow#10*, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, and sorbitol

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

DAYTIME MULTI-SYMPTOM

Cold & Flu Relief

325 mg - Acetaminophen (Pain Reliever / Fever Reducer)

10 mg - Dextromethorphan HBr (Cough Suppressant)

5 mg - Phenylephrine HCl (Nasal Decongestant)

  • Aches, Fever & Sore Throat
  • Cough
  • Nasal Congestion

Non-Drowsy

Alcohol Free • Antihistamine Free

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

Compare to the Active Ingredients in Vicks® DayQuil® Cold & Flu LiquiCaps®†

†This product is not manufactured or distributed by The Procter & Gamble company, Vicks®, DayQuil®, LiquiCaps® are registered trademarks of The Procter and Gamble company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

Product Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg

Fred's Pharmacy Daytime Multi-Symptom Cold & Flu Relief

DAYTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-468
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
CARMINIC ACID (UNII: CID8Z8N95N)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P19;95A;512;P119
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-468-162 in 1 CARTON12/18/201505/20/2022
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:55315-468-243 in 1 CARTON12/18/201505/20/2022
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/18/201505/20/2022
Labeler - Freds Inc (005866116)

Revised: 5/2024
 
Freds Inc