FDA Label for Daytime Cold/flu Relief

View Indications, Usage & Precautions

Daytime Cold/flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Army And Air Force Exchange Service. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts

Active ingredients
(in each Softgel)

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

Dextromethorphan HBr ......10 mg

Phenylephrine HCl .........5 mg


Otc - Purpose



Purpose

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

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

Phenylephrine HCl ............... Antihistamine


Indications & Usage



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


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.


Otc - Ask Doctor



Ask a doctor before use if you have
■ liver disease                  ■ heart disease
■ thyroid disease              ■ diabetis
■ high blood pressure
■ trouble urinating due to an enlarged prostate
  gland
■ cough that occurs with too much phlegm
   (mucus)
■ persistant or chronic cough as occurs with
   smoking, asthma or emphysema


Otc - Ask Doctor/Pharmacist



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


Otc - When Using



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


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


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 4 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 FD&C
Red No. 40, FD&C Yellow No.6,
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 Daytime Cold/Flu Relief



exchange select

DayTime

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.