DAYTIME COLD AND FLU capsule, liquid filled

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

Purpose

Pain reliever/fever reducer
Cough suppressant

Use(s)

temporarily relieves these symptoms due to cold flu:

• cough
• sore throat
• headache
• minor aches and pains
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 10 softgels 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

Do not use if you have

• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients
• in children under 12 years of age

Ask a doctor before use if you

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough with excessive phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if

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 gets worse or lasts more than 7 days
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.
nervousness, dizziness, or sleeplessness occurs

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children

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

• do not take more than the recommended dose
  
  Adults and children 12 years and over: Take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor

     Children under 12 years: Do not use

Other information

• store at room temperature 20-25°C (68-77°F)
• avoid excessive heat
• do not use if blister unit is torn or open

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12,
Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White Edible Ink

Questions/Comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

Daytime Cold and Flu

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU 
daytime cold and flu capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-474
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

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 400 (UNII: B697894SGQ)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-474-29	1 in 1 CARTON	01/09/2026
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69168-474-51	2 in 1 CARTON	01/09/2026
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/09/2026

Labeler - Allegiant Health (079501930)