Daytime NiteTime

Kroger Company

Kroger Co. Day Time and Nite Time Cold/Flu Relief Combo Pack Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 15 mL tablespoon) (for Nighttime)
• Active ingredient (in each 15 mL tablespoon)  (for Daytime)
• Purpose (for Nighttime)
• Purpose (for Daytime)
• Daytime NiteTime 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 these products
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Daytime NiteTime Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL tablespoon) (for Nighttime)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredient (in each 15 mL tablespoon)  (for Daytime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (for Nighttime)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose (for Daytime)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Daytime NiteTime Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion (Daytime only)
• sore throat
• cough due to minor throat and bronchial irritation
• headache
• minor aches and pains
• fever
• runny nose and sneezing (Nighttime only)

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if:

• adult takes more than 4 doses in 24 hours (Nighttime) or more than 6 doses in 24 hours (Daytime), which is the maximum daily amount
• child takes more than 5 doses in 24 hours (Daytime)
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using these products

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.
• to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using these products

• do not use more than directed

In addition, when using Nighttime:

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

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless (Daytime only)
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take as recommended - see Liver warning
• take Nighttime OR Daytime
• use dose cup

Nighttime Liquid

• do not exceed 4 doses per 24 hours

Daytime Liquid

• do not exceed 5 doses (children) or 6 doses (adults) per 24 hours

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Daytime NiteTime Other information

• each TBSP of Nighttime contains: sodium 18 mg
• each TBSP of Daytime contains: sodium 7 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavors, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-632-6900

Principal Display Panel

 Sealed with printed neckband for your protection. If missing or broken return to store.

Save when you buy Day Time and Nite Time!

(For Daytime)

Compare to active ingredients of Vicks® DayQuil® - see bottom panel

Alcohol Free/Antihistamine Free

See New Warnings Information

Multi-Symptom Cold/Flu Relief

Non-Drowsy

Day Time

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Nasal Decongestant - Phenylephrine HCl

Aches/Fever

Cough

Nasal Congestion

Original Flavor

(For Nighttime)

Compare to active ingredients of Vicks® NyQuil® - see bottom panel

Alcohol 10%

See New Warnings Information

Multi-Symptom Cold/Flu Relief

Nite Time

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Antihistamine - Doxylamine Succinate

Aches/Fever

Cough/Sneezing

Runny Nose

Cherry Flavor