Otc - Active Ingredient
Drug Facts
Active ingredients
(in each Softgel)
Acetaminophen ................325 mg
Dextromethorphan HBr ......15 mg
Doxylamine succinate .........6.25 mg
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.
Drug Facts
Active ingredients
(in each Softgel)
Acetaminophen ................325 mg
Dextromethorphan HBr ......15 mg
Doxylamine succinate .........6.25 mg
Purpose
Acetaminophen ........................Pain reliever/Fever reducer
Dextromethorphan HBr .............Cough suppressant
Doxylamine succinate ............... Antihistamine
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 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: ■ 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 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 a doctor or pharmacist before use if you are
■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin
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 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a
Poison Control Center right away.
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.
Directions
■ take only as directed (see Warning)
■ do not exceed 4 doses per 24 hours
adults & | 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 information
■ Store at room temperature 20-25° C (68-77° F)
■ avoid excessive heat
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? Call Weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
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
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