Daytime And Nighttime Cold/flu Relief Softgels - Combo Pack Kit
FDA Label NDC 55301-605

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Army And Air Force Exchange Service for the product Daytime And Nighttime Cold/flu Relief Softgels - Combo Pack (NDC 55301-605). 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 ------------, otc - active ingredient, otc - purpose, indications & usage, other, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DayTime COLD/FLU RELIEF

Nighttime COLD/FLU RELIEF

Indications & Usage

Usestemporarily relieves common cold/flu
symptoms: ■ nasal congestion ■cough due to
to minor throat & bronchial irritation ■ sore
throat ■ headache ■ minor aches and pains
■ fever

Uses temporarily relieves common cold/flu
symptoms: ■ cough due to minor throat &
bronchial irritation ■ sore throat ■ headache
■ minor aches and pain ■ fever ■ runny
nose & sneezing

Otc - Do Not Use

Do not use:

■ with any other products 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.

Do not use: ■ with any other products 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.

■ to make a child sleep.

Otc - Ask Doctor/Pharmacist

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

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

Otc - When Using

When using this product, do not use more than directed.

When using this product

■ 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

Otc - Stop Use

Stop use and ask a doctor if

■ you get nervous, dizzy or sleepless
■ symptoms get worse or last more
than 5 days (children) or 7 days (adults)
■ 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.

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.

Otc - Pregnancy Or Breast Feeding

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Other Safety Information

In case of accidental overdose, get medical
help or contact a Poison Control Center right
away. Quick medical attention is critical for
adults as well as children, even if you do not
notice any signs or symptoms.

Other information
■ Store at room temperature 20-25° C (68-77° F)
■ avoid excessive heat

In case of accidental overdose, get medical
help or contact a Poison Control center right
away. Quick medical attention is critical for
adults as well as children, even if you do not
notice any signs or symptoms.

Inactive Ingredient

Inactive ingredients FD&C Red # 40, FD&C Yellow # 6,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide

Inactive ingredients
D&C Yellow # 10, FD&C
Blue # 1, Gelatin, Glycerin,
Polyethylene glycol,
Povidone, Propylene glycol,
Purified water, Sorbitol
sorbitan solution, Titanium
dioxide.

Storage And Handling

Other information
■ Store at room temperature 20-25° C (68-77° F)
■ avoid excessive heat

* Please review the disclaimer below.