Night-time Cold And Flu Relief Capsule, Liquid Filled
FDA Label NDC 69517-161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthlife Of Usa for the product Night-time Cold And Flu Relief (NDC 69517-161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each softgels), purpose, uses, warnings, keep out of reach of children, direction, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Softgels)

→ Purpose

→ Uses

→ Warnings

→ Keep Out Of Reach Of Children

→ Direction

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Distributed By:

→ Package Label

Active Ingredients (In Each Softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

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 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, 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.

Ask a doctor before use if you have

liver disease
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

When using this product

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drink
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor 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 signs of a serious condition.

Keep Out Of Reach Of Children

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.

Direction

take only as directed
do not exceed 4 doses per 24 hours


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

Other Information

store at room temperature.
TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Inactive Ingredients

D&C Yellow No.10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, methyl paraben, propyl paraben.