Cold Head Congestion Daytime / Nighttime (acetaminophen 325 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each night caplet)	Purpose
Acetaminophen 325 mg	Pain reliever
Chlorpheniramine maleate 2 mg	Antihistamine
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • runny nose and sneezing
  • cough
  • sinus congestion and pressure
• helps clear nasal passages
• relieves cough to help you sleep

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

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage

In addition, when using Cold Head Congestion Night:

• excitability may occur, especially in children
• marked 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

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, 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 SECTION

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. 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 overdose warning)
• do not take Day and Night caplets at the same time
• do not take more than a total of 12 caplets in 24 hours

adults and children 12 years and over	take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve
children under 12 years	do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

• store between 20°-25°C (68°-77°F) in a dry place
• retain carton for complete product information

Inactive Ingredients

Cold Head Congestion Day acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Cold Head Congestion Night acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048

Principal Display Panel - Kit Carton

RESTORE u

NDC 57344-162-02

^†COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® COLD HEAD CONGESTION DAY & NIGHT

DAYTIME & NIGHTTIME

Cold HEAD CONGESTION Pain Reliever, Nasal Decongestant, Cough Suppressant, Antihistamine*

• Headache/Sore Throat – Acetaminophen
• Nasal Congestion – Phenylephrine HCl
• Coughing – Dextromethorphan HBr
• Runny Nose* – Chlorpheniramine Maleate*

*Antihistamine in Nighttime Only

COOL TASTE

20 CAPLETS 12 DAY / 8 NIGHT CAPLETS