DAYTIME COLD AND FLU RELIEF- daytime cold and flu relief capsule, liquid filled 
TopCo Associates, LLC

----------

417 - Daytime Cold and Flu Relief

Active ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Use(s)

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• 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,
occurs with 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 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 • thyroid disease • diabetes • high blood pressure
• 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, or emphysema

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
• 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 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

adults and children 12 years & over: 2 softgels with water every 4 hours

children 4 to under 12 years: ask a doctor

children under 4 years: do not use

Other information

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/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Daytime Cold and Flu

Daytime Cold and Flu

DAYTIME COLD AND FLU RELIEF 
daytime cold and flu relief capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-065
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:76162-065-161 in 1 CARTON11/03/2023
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/03/2023
Labeler - TopCo Associates, LLC (006935977)

Revised: 10/2023
Document Id: 97e61aee-34b7-468d-b3ea-6d796d4365da
Set id: d592fbb8-d4bf-444e-982e-edf6fe97dce4
Version: 3
Effective Time: 20231031
 
TopCo Associates, LLC