DAYTIME COLD AND FLU- acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg capsule 
Allegiant Health

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417- Daytime Cold and Flu

Active ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Use(s)

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

Warnings

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

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or followed by fever,  headache, rash, nausea, or vomiting, see 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 drugs. 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

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

Ask a doctor or pharmacist before use if

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
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days n redness or swelling is present
  • new symptoms occurs
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

Taking more than directed can cause serious health problems. 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

take only as directed

Other information

do not use if blister unit is torn or open

Storage

store at room temperature 20-25 °C (68-77° F)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink

Questions

Call 1-888-952-0050 Monday through Friday

Principal Display Panel

Daytime Cold and Flu

Daytime Cold and Flu


DAYTIME COLD AND FLU 
acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-417
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
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)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code PC9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-417-512 in 1 CARTON11/11/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69168-417-298 in 1 BLISTER PACK; Type 0: Not a Combination Product11/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/11/2020
Labeler - Allegiant Health (079501930)

Revised: 11/2020
Document Id: c2498c7c-a983-4ee4-b796-e0f844c9fcd0
Set id: bed5f9dc-45ea-4e90-86c6-86599b6f3861
Version: 3
Effective Time: 20201116
 
Allegiant Health