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

Daytime Cold and Flu by

Drug Labeling and Warnings

Daytime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 

• more than 4 doses in  24 hours, 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

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

• do not exceed 4 doses per 24 hours
• Adults and children 12 years and 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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-417
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	PC9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-417-51	2 in 1 CARTON	11/11/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69168-417-29	8 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/11/2020

Labeler - Allegiant Health (079501930)