Acetaminophen 325 mg , Dextromethorphan Hydrobromide 10 mg, Doxylamine Succinate 6.25 mg and Phenylephrine Hydrochloride 5 mg (Night Time Severe)

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:35:12

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each Softgel)

Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant

Uses

Uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage

Warnings

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 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, persists 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.

Ask a doctor before use if you have

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers taking the blood thinning drug warfarin

Directions And Dosage

Overdosage

In case of overdose, get medical help or contact a Poison Control Center 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 8 Softgels per 24 hrs Adults & children 12 years & 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 Label Information

Inactive ingredients

FD&C Blue No.1, D&C Yellow No.10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol sorbitan solution.

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

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 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

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. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdosage

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center 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

DOSAGE & ADMINISTRATION SECTION

take only as directed do not exceed 8 Softgels per 24 hrs Adults & children 12 years & 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

OTHER SAFETY INFORMATION

Store at no greater than 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No.1, D&C Yellow No.10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol sorbitan solution.

TAMPER EVIDENT

SPL UNCLASSIFIED SECTION

This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.

Manufactured by

SPL UNCLASSIFIED SECTION

Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam Village, Kancheepuram District, Tamilnadu - 603 103, India. Mfg. Lic. No.: XXXXXXXXXXXX

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc47c7e929-e897-88c0-e063-6394a90a5821.xml2026-01-29
otc2090307f-cab8-709f-e063-6294a90aa7cc.xml2024-08-27
otc1fcbafaa-c872-db6d-e063-6394a90aab5e.xml2024-08-23
otcnight-time-severe-carton.jpg2024-08-23