FDA Label for Nighttime Cold/flu Relief

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

■ 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

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