FDA Label for Cold And Flu Daytime, Nighttime, Multi-symptom

View Indications, Usage & Precautions

Cold And Flu Daytime, Nighttime, Multi-symptom Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.

Active Ingredients (In Each Liquid-Filled Capsule) (Daytime Cold & Flu)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Active Ingredients (In Each Liquid-Filled Capsule) (Nighttime Cold & Flu)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Uses

temporarily relieves common cold and flu symptoms:
- fever
- headache
- sore throat
- minor aches and pains
- cough due to minor throat and bronchial irritation
- nasal congestion (Daytime only)
- runny nose and sneezing (Nighttime only)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

with any other drug 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.
if you have ever had an allergic reaction to this product or any of its ingredients
to make a child sleepy (Nighttime only)

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)
liver disease
difficulty in urination due to enlargement of the prostate gland
heart disease (Daytime only)
diabetes (Daytime only)
thyroid disease (Daytime only)
high blood pressure (Daytime only)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
glaucoma (Nighttime only)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Nighttime only)

When Using This Product

do not exceed recommended dosage
excitability may occur, especially in children (Nighttime only)
avoid alcoholic beverages (Nighttime only)
marked drowsiness may occur (Nighttime only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop Use And Ask A Doctor If

nervousness, dizziness, or sleeplessness occur (Daytime only)
pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
pain or cough gets worse or lasts more than 7 days (Nighttime only)
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions (Daytime Only)

do not take more than directed
do not take more than 8 capsules per 24 hours
adults and children 12 years and over: take 2 capsules with water every 4 hours
children under 12 years: ask a doctor

Directions (Nighttime Only)

do not take more than directed
do not take more than 8 capsules per 24 hours
adults and children 12 years and over: take 2 capsules with water every 6 hours
children under 12 years: ask a doctor

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from heat, humidity and light
see end flap for expiration date and lot number

Inactive Ingredients (Daytime Only)

FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene
glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,
titanium dioxide

Inactive Ingredients (Nighttime Only)

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,
titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to Vicks® DayQuil® &
NyQuil® Cold & Flu LiquiCaps®
active ingredients†

DAYTIME • NON DROWSY
Cold & Flu

ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
PHENYLEPHRINE HCl /
NASAL DECONGESTANT

MULTI-SYMPTOM

ACTUAL
SIZE

32
LIQUID
CAPS

NIGHTTIME
Cold & Flu

ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE /
ANTIHISTAMINE