night time sinus

Kroger Company

Kroger Co. Night Time Sinus Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• night time sinus Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• night time sinus Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

night time sinus Uses

• •for the temporary relief of:
• •headache
• •sinus congestion and pressure
• •nasal congestion
• •runny nose and sneezing
• •minor aches and pains
• •reduces swelling of nasal passages
• •helps decongest sinus openings and passages

Warnings

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

• •more than 12 caplets in 24 hours, which is the maximum daily amount
• •with other drugs containing acetaminophen
• •3 or more alcoholic drinks every day while using this product

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.
• •to make a child sleepy

Ask a doctor before use if you have

• •liver disease
• •heart disease
• •high blood pressure
• •thyroid disease
• •diabetes
• •trouble urinating due to an enlarged prostate gland
• •a breathing problem such as emphysema or chronic bronchitis
• •glaucoma

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
• •drowsiness may occur
• •alcohol, sedatives and tranquilizers may increase drowsiness
• •avoid alcoholic drinks
• •be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• •you get nervous, dizzy or sleepless
• •pain or nasal congestion 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

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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• •do not take more than directed (see Liver warning)

take 2 caplets every 4-6 hours

swallow whole – do not crush, chew or dissolve

do not take more than 12 caplets in 24 hoursdo not use this adult product in children under 12 years of age

•

•

•

•

adults and children 12 years and over
children under 12 years

night time sinus Other information

• • store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, carnauba wax, flavor, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COOL ICE®

INSTANT COOLING SENSATION

COMPARE TO active ingredients of TYLENOL® SINUS CONGESTION & PAIN

See end panel

SEE NEW WARNINGS INFORMATION

NIGHT TIME

Sinus

Congestion & Pain

Pain Reliever/Nasal Decongestant/Antihistamine

Acetaminophen/Phenylephrine HCl/Chlorpheniramine Maleate

Headache

Sinus Pressure

Nasal Congestion

Runny Nose

night time sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET Product Information Product Type Human otc drug label Item Code (Source) NDC:30142-935 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 325 mg Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM carnauba wax ferric oxide red FERRIC OXIDE YELLOW cellulose, microcrystalline POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES STEARIC ACID talc titanium dioxide Product Characteristics Color Size Imprint Code Shape WHITE (off white) 16 mm L476 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK 2 NDC:30142-935-53 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2011-07-31