Daytime Cold And Flu Mini Softgels

Daytime Cold And Flu Mini Softgels
SPL v3
SPL
SPL Set ID 63cb19d4-2306-4723-a95e-9d2d8b9eccd0
Route
ORAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Butylated Hydroxyanisole Fd&c Yellow No. 6 Gelatin Glycerin Methylparaben Polyethylene Glycol 400 Propylene Glycol Propylparaben Povidone Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: SDM Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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 & for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless

• pain, nasal congestion or 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.

Section 50567-7

When using this product

• do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have

• liver disease

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

uses
  • temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache n cough
  • nasal congestion
  • sore throat
  • sinus congestion and pressure
  • temporarily reduces fever
Warnings

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

• more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks daily 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, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than the recommended dose
  • adults & children 12 yrs & over: take 2 Softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor
  • children under 12 yrs: do not use

Other Information
  • store between 20-25°C (68-77°F).
  • Avoid high humidity and excessive heat.
Inactive Ingredients

FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol, povidone, purified water,

silver sheen, sorbitol solution

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Daytime Cold & Flu

Multi-Symptom Relief

mini softgels

Carton

Active Ingredient (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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 & for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless

• pain, nasal congestion or 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.

Section 50567-7 (50567-7)

When using this product

• do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• liver disease

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

uses (Uses)
  • temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache n cough
  • nasal congestion
  • sore throat
  • sinus congestion and pressure
  • temporarily reduces fever
Warnings

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

• more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks daily 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, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than the recommended dose
  • adults & children 12 yrs & over: take 2 Softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor
  • children under 12 yrs: do not use

Other Information (Other information)
  • store between 20-25°C (68-77°F).
  • Avoid high humidity and excessive heat.
Inactive Ingredients (Inactive ingredients)

FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol, povidone, purified water,

silver sheen, sorbitol solution

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Daytime Cold & Flu

Multi-Symptom Relief

mini softgels

Carton

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)