DAYTIME COLD AND FLU- acetaminophen and dextromethorphan hydrobromide 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 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Uses

Temporarily relieves common cold/flu symptoms:

• 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

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, lasts 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

When using this product do not exceed recommended dose.

Stop use and ask a doctor if

• pain or cough gets worse or lasts 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 breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Prompt 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 (see overdose warning)
• Do not take more than 4 doses in 24 hours.

• adults and children 12 years and over: 2 softgels with water every 4 hours
• children 4 to under 12 years: consult a doctor
• children under 4 years: do not use

Other information

• Store at 15° - 30 °C (59°- 86 °F)
• Read all product information before using.
• Tamper evident: Do not use if carton is open or blister unit is broken.

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 ink.

QUESTIONS OR COMMENTS?

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PRINCIPAL DISPLAY PANEL

Daytime Cold and Flu Capsules (PE free)

Each softgel contains: Acetaminophen 325mg/ Dextromethorphan HBr 10mg

NDC: 53345-056-01

Caution: for further manufacturing, processing or repackaing

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU 
acetaminophen and dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53345-056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN TYPE B BOVINE (150 BLOOM) (UNII: F5AJW0ONK4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POVIDONE K12 (UNII: 333AG72FWJ)
SORBITAN (UNII: 6O92ICV9RU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	orange (Clear)	Score	no score
Shape	CAPSULE (oblong)	Size	17mm
Flavor		Imprint Code	P41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-056-01	1 in 1 CARTON	12/28/2025
1		4000 in 1 BAG; 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	12/28/2025

Labeler - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd (421293287)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(53345-056)