FDA Label for Daytime And Nighttime Cold/flu Relief Softgels - Combo Pack

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DayTime COLD/FLU RELIEF

Nighttime COLD/FLU RELIEF

Otc - Active Ingredient

Drug Facts

Active ingredients
(in each Softgel)

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

Dextromethorphan HBr ......10 mg

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

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

Phenylephrine HCl ............... Nasal Decongestant

Purpose

Acetaminophen ........................Pain reliever/fever reducer

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

Doxylamine succinate ............... Antihistamine

Indications & Usage

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

Uses temporarily relieves common cold/flu
symptoms: ■ cough due to minor throat &
bronchial irritation ■ sore throat ■ headache
■ minor aches and pain ■ fever ■ runny
nose & sneezing

Other

Warnings Liver warning: This product
contains acetaminophen. Severe liver
damage may occur if you take ■ more than
4 doses 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 a 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.

Warnings Liver warning: This product
contains acetaminophen. Severe liver
damage may occur if you take ■ more than
4 doses 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.

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 ■ heart disease
■ thyroid disease ■ diabetes
■ high blood pressure
■ trouble urinating due to enlarged prostate
gland
■ cough that occurs with too much phlegm
(mucus)
■ persistant or chronic cough as occurs with
smoking, asthma or emphysema

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 enlarged prostate
gland

Otc - Ask Doctor/Pharmacist

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

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.

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 & tranquilizers may
increase drowsiness

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.

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.

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Other Safety Information

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.

Other information
■ Store at room temperature 20-25° C (68-77° F)
■ avoid excessive heat

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 Warnings)
■ do not exceed 4 doses per 24 hours

■ even if taking DayTime during day and Nighttime during night, total
limit per day is 4 doses per 24-hour period.

Directions
■ take only as directed (see Warnings)
■ do not exceed 4 doses per 24 hours

■ even if taking DayTime during day and Nighttime during night, total
l  imit per day is 4 doses per 24-hour period.

Inactive Ingredient

Inactive ingredients FD&C Red # 40, FD&C Yellow # 6,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide

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

Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

Storage And Handling

Other information
■ Store at room temperature 20-25° C (68-77° F)
■ avoid excessive heat

Principal Display Package Label: Exchange Select Daytime And Nighttime Cold/Flu Relief Softgels - Combo Pack

DayTime Cold/Flu Relief Nighttime Cold/Flu Relief

32 Softgels   /   16 Softgels

**Compare to the active ingredients in                                  **Compare to the active ingredients in
   Vicks® DayQuil® Cold and Flu LiquiCaps®                              Vicks® NyQuil® Cold and Flu Liquicaps®

**This product is not manufactured or                                     **This product is not manufactured or
distributed by Procter & Gamble, owner of                                  distributed by Procter & Gamble, owner of
the registered trademark Vicks® DayQuil®                                 the registered trademark Vicks® NyQuil®
Cold & Flu LiquiCaps®.                                                              Cold & Flu LiquiCaps®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS
AND PRODUCT INFORMATION.

SATISFACTION GUARANTEED OR YOUR MONEY BACK.

Manufactured For Your Military Exchanges
By AptaPharma Inc.,
1533 Union Avenue, Pennsauken, NJ 08110
1-877-798-5944 aptapharma.com

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