Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate

Capsules (Night time) · Softgel Healthcare Private Limited

Dosage Form

Capsules (Night time)

Manufacturer

Softgel Healthcare Private Limited

Active ingredients

ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE15 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever
runny nose & sneezing

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

35916-0154-1

Full prescribing information (for healthcare professionals)

TAMPER EVIDENT

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

Manufactured by

Softgel Healthcare Pvt Ltd.,

Survey no. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu – 603103, India

Mfg. Lic. No: xxxxxxxxxxxxxx

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adults & children 12 yrs & over	2 softgels with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Do not use if…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.

Ask a doctor before use if…pain 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…

Ask a doctor or pharmacist before use if…taking sedatives or tranquilizers taking the blood thinning drug warfarin

Stop use and talk to a doctor if…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 oxidas…

Package labelNDC Code: 35916-0154-1 *Compared to the active ingredient in VICKS ® NyQuil TM Cold & F Liquicaps TM Acetaminophen 325 mg, Dextromethorphan Hbr 15 mg and Doxylamine Succinate 6.25 mg Softgelatin Capsules Fever, Sore Thro…

What it looks like

Package codes (NDC)

TAMPER EVIDENT

Manufactured by

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