NIGHTTIME COLD/FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Nighttime Cold/Flu Relief by

Drug Labeling and Warnings

Nighttime Cold/Flu Relief by is a Otc medication manufactured, distributed, or labeled by ARMY AND AIR FORCE EXCHANGE SERVICE, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients
(in each Softgel)

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

Dextromethorphan HBr ......15 mg

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

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.

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.

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

ASK DOCTOR/PHARMACIST

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

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

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.

PREGNANCY OR BREAST FEEDING

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

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 &children12 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 20-25º C (68-77º 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.

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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INGREDIENTS AND APPEARANCE

NIGHTTIME COLD/FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-603
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325.0 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15.0 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	603
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-603-03	2 in 1 CARTON	01/01/2025
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2025

Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(55301-603)