49483-726_timely_maximum Strength Day Cold & Flu And Night Severe Cold & Flu Tablets

SPL v1

SPL

SPL Set ID fff69901-965c-5372-e053-6394a90a29c2

Route

ORAL

Published

Effective Date 2023-07-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Triprolidine (1.25 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Povidone Titanium Dioxide Talc Silicon Dioxide Crospovidone, Unspecified Polyethylene Glycol, Unspecified Mica Stearic Acid Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: N1 Shape: capsule Color: red Color: yellow Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-21

Description

Active ingredients (in each caplet) Day Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each caplet) Night Severe Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Triprolidine HCl 1.25 mg

Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4,000 mg in 24 hours, which is the maximum daily amount

• 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

Uses

Day Cold & Flu

• temporarily relieves these common cold and flu symptoms:

o cough

o nasal congestion

o minor aches and pains

o sore throat

o headache

o stuffy nose

o sinus congestion and pressure

• temporarily reduces fever

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Night Severe Cold & Flu

• temporarily relieves these common cold and flu symptoms:

o cough

o nasal congestion

o minor aches and pains

o sore throat

o headache

o sneezing

o sinus congestion and pressure

o runny nose

o itching of the nose or throat

o itchy, watery eyes due to hay fever

• temporarily reduces fever

• controls cough to help you get to sleep

Dosage and Administration

Directions

Day Cold & Flu

• do not take more than directed (see Overdose warning)

• do not take more than 12 caplets in any 24-hour period

• adults and children 12 years of age and over: take 2 caplets every 4 hours

• children under 12 years of age: do not use

Night Severe Cold & Flu

• do not take more than directed (see Overdose warning)

• do not take more than 8 caplets in any 24-hour period

• adults and children 12 years of age and over: take 2 caplets every 4 hours

• children under 12 years of age: do not use

Description

Section 34088-5

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
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 fever, rash, or headache that lasts. These could be signs of a serious condition.

Section 50567-7

When using this product

• do not use more than directed

• excitability may occur, especially in children (Night Severe Cold & Flu only)

• marked drowsiness may occur (Night Severe Cold & Flu only)

• alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only)

• avoid alcoholic drinks (Night Severe Cold & Flu only)

• use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)

Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers (Night Severe Cold & Flu only)

Section 50569-3

Ask a doctor before use if you have

• liver disease

• heart disease

• diabetes

• high blood pressure

• thyroid disease

• glaucoma (Night Severe Cold & Flu only)

• trouble urinating due to an enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only)

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

• cough that occurs with too much phlegm (mucus)

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 51727-6

Inactive ingredients Day Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Inactive ingredients Night Severe Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide

Section 51945-4

Section 53413-1

Questions or Comments?

Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purposes

Day Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Night Severe Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Section 55106-9

Active ingredients (in each caplet)

Day Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet)

Night Severe Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg

Section 60561-8

Other information

store at 20-25°C (68-77°F)

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Directions

Warnings and Precautions (34071-1)

Section 34088-5 (34088-5)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
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 fever, rash, or headache that lasts. These could be signs of a serious condition.

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers (Night Severe Cold & Flu only)

Section 50569-3 (50569-3)

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 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Day Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Night Severe Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Day Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet)

Night Severe Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg

Section 60561-8 (60561-8)

Other information

store at 20-25°C (68-77°F)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Day Cold & Flu • temporarily relieves these common cold and flu symptoms: o cough o nasal congestion o minor aches and pains o sore throat o headache o stuffy nose o sinus congestion and pressure • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Night Severe Cold & Flu • temporarily relieves these common cold and flu symptoms: o cough o nasal congestion o minor aches and pains o sore throat o headache o sneezing o sinus congestion and pressure o runny nose o itching of the nose or throat o itchy, watery eyes due to hay fever • temporarily reduces fever • controls cough to help you get to sleep", "34068-7": "Directions Day Cold & Flu • do not take more than directed (see Overdose warning) • do not take more than 12 caplets in any 24-hour period • adults and children 12 years of age and over: take 2 caplets every 4 hours • children under 12 years of age: do not use Night Severe Cold & Flu • do not take more than directed (see Overdose warning) • do not take more than 8 caplets in any 24-hour period • adults and children 12 years of age and over: take 2 caplets every 4 hours • children under 12 years of age: do not use", "34071-1": "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4,000 mg in 24 hours, which is the maximum daily amount • 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "34088-5": "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 fever, rash, or headache that lasts. These could be signs of a serious condition.", "50567-7": "When using this product • do not use more than directed • excitability may occur, especially in children (Night Severe Cold & Flu only) • marked drowsiness may occur (Night Severe Cold & Flu only) • alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only) • avoid alcoholic drinks (Night Severe Cold & Flu only) • use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)", "50568-5": "Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers (Night Severe Cold & Flu only)", "50569-3": "Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • glaucoma (Night Severe Cold & Flu only) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough that occurs with too much phlegm (mucus)", "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.", "51727-6": "Inactive ingredients Day Cold & Flu colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide Inactive ingredients Night Severe Cold & Flu colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide", "53413-1": "Questions or Comments? Call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purposes Day Cold & Flu Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Purposes Night Severe Cold & Flu Pain reliever/fever reducer Cough suppressant Nasal decongestant Antihistamine", "55106-9": "Active ingredients (in each caplet) Day Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each caplet) Night Severe Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Triprolidine HCl 1.25 mg", "60561-8": "Other information store at 20-25°C (68-77°F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:28.430529 · Updated: 2026-03-14T23:01:27.375563