CALMADOL PLUS- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Calmadol Plus by

Drug Labeling and Warnings

Calmadol Plus by is a Otc medication manufactured, distributed, or labeled by Grandall Distributing Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves the following cold/flu symptoms minor aches and pains  sore throat cough  sneezing and runny nose  headache nasal congestion  stuffy nose temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:  more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount  with other drugs containing acetaminophen

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.

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

Directions

• this product does not contain directions or complete warnings for adult use
• mL = milliliter
• shake well before using
• do not give more than 5 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product
• if needed, repeat dose every 4 hours while symptoms last
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (yr)	Dose (mL)
48-95	6-11	10 mL
36-47	4-5	do not use unless directed by a doctor
under 36	under 4	do not use

Other information

store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Package Labeling:

INGREDIENTS AND APPEARANCE

CALMADOL PLUS 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48201-009-01	1 in 1 BOX	06/16/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/16/2016

Labeler - Grandall Distributing Co., Inc. (044428324)