Nighttime Cold/flu Relief Capsule, Liquid Filled
FDA Label NDC 55301-603

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 Nighttime Cold/flu Relief (NDC 55301-603). 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, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Drug Facts

Active ingredients
(in each Softgel)

Acetaminophen ................325 mg

Dextromethorphan HBr ......15 mg

Doxylamine succinate .........6.25 mg

Otc - Purpose

Purpose

Acetaminophen ........................Pain reliever/Fever reducer

Dextromethorphan HBr .............Cough suppressant

Doxylamine succinate ............... Antihistamine

Indications & Usage

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

Warnings

Warnings Liver warning: This product
contains acetaminophen. Severe liver
damage may occur if you take ■ more than
4doses in 24 hrs, 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 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, occurs
with or is followed by fever, headache, rash,
nausea or vomiting, consult a doctor
promptly.

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 ■ to make a child sleep.

Otc - Ask Doctor

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 an enlarged prostate
gland

Otc - Ask Doctor/Pharmacist

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.
■ 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, and tranquilizers may
increase drowsiness

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Overdosage

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.

Dosage & Administration

Directions
■ take only as directed (see Warning)
■ do not exceed 4 doses per 24 hours

adults &
children
12 yrs
& over

2 soft gels with water every 6 hours

children 4 to under 12 years:

ask a doctor

children under 4 years:

 do not use

■ When using other
Daytime or Nighttime
products, carefully read
each label to ensure
correct dosing.

Other Safety Information

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

Inactive Ingredient

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

Otc - Questions

Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

Product Label: Exchange Select Nighttime Cold/Flu Relief

exchange select

Nighttime

Cold/Flu Relief

24 Softgels

Manufactured For Your Military Exchange

By AptaPharma Inc.,

1533 Union Avenue, Pennsauken, NJ 08110

1-877-798-5944

aptapharma.com

res

* Please review the disclaimer below.