DAYTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled 
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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
  • new symptoms occur
  • nervousness, dizziness or sleeplessness 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 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 insure correct dosing

Other information

  • store at room temperature 15º-30ºC (59º-86ºF)
  • avoid excessive heat

Inactive ingredients

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

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

**COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL®

Non-Drowsy

Daytime

COLD/FLU RELIEF

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCl

Pain Reliever • Fever Reducer • Cough Suppressant • Nasal Decongestant

Softgels

**This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® LiquiCaps®.

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: CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD. SUITE 101

BOCA RATON, FL 33431

Product Label

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

Premier Value Daytime Cold Flu Softgel

 

DAYTIME  COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-199
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)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code P19;95A;36A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-199-162 in 1 CARTON11/15/201206/01/2018
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-199-242 in 1 CARTON11/15/201206/01/2018
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/15/201206/01/2018
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2021
 
Chain Drug Consortium, LLC