FDA Label for Daytime Cold/flu Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRODUCT LABEL: EXCHANGE SELECT DAYTIME COLD/FLU RELIEF
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.